The clinical and cost effectiveness of advances in hearing aid technology

Report to the National Institute for Clinical Excellence

Authors: R.S.Taylor & S.Paisley

Titles & Institutions: Head of Appraisals, National Institute for Clinical Excellence & Honorary Senior Lecturer, Department of Public Health & Policy, School of Hygiene & Tropical Medicine, London. Senior Information Officer, School of Health and Related Research (ScHARR), University of Sheffield.

Date of most recent update: Expiry date:

14th June 2000 May 2001

TABLE OF CONTENTS

ABBREVIATIONS

EXECUTIVE SUMMARY 1. INTRODUCTION 1.1 Background 1.1.1 Description of underlying health problem 1.1.2 Current treatment options and service provision 1.1.3 Hearing aid technology current NHS provision & development in technology 1.1.4 Evaluating the benefits of hearing aid developments 1.2 Aim of review 2. METHODS 2.1 Search strategy 2.2 Inclusion / exclusion criteria 2.3 Quality assessment and data extraction of included studies 2.4 Data analysis and presentation 3. RESULTS 3.1 Quality of research available 3.2 Assessment of clinical effectiveness 3.3 Assessment of cost effectiveness 4. DISCUSSION 4.1 Clinical effectiveness 4.2 Cost effectiveness 4.3 Current research 5. CONCLUSION 6. REFERENCES

2-3 4-10 4-6 6-7 7-9 9-10 10 11-13 11 11-12 12 12-13 14-21 14 14-19 14-21 22-25 22-23 23-24 24-25 25 26-28

APPENDICES 1. 2. 3. 4. Search strategies for Medline Other hearing aid comparisons Awaiting further information from authors/manufacturers Excluded studies (failed to meet review inclusion/exclusion criteria)

ABBREVIATIONS

APHAB: AGC: BEA: BTA: CIC: Db HL: DSP: GHABP: HHIE: HRQOL: ITC: ITE: QALY: RCT: SPIN: WDRC:

Abbreviated Profile of Hearing Benefit Automatic gain control Better ear average Behind the ear (hearing aid) Completely in the canal (hearing aid) Decibel hearing level Digital signal processing Glasgow Hearing Aid Benefit Profile Hearing Handicap Inventory for the Elderly Health related quality of life In the canal (hearing aid) In the ear (hearing aid) Quality adjusted life year Randomised controlled trial Speech Perception in Noise Wide dynamic range compression

EXECUTIVE SUMMARY

Aim The aim of this review is to assess the clinical and cost effectiveness of developments in hearing aid technology (in particular, digital hearing aids) in comparison to the current NHS analogue hearing aid range. Methods A search of electronic databases aimed at identifying randomised controlled trials, controlled randomised cross over trials and economic studies relating to digital hearing aid comparisons was undertaken; Medline, Embase, Science Citation Index, Cochrane Database of Systematic Reviews (CDSR), Cochrane Controlled Trials Register (CCTR) and the NHS Centre for Reviews and Dissemination databases (DARE, NHS EED, HTA). The publication lists and current research registers of health technology assessment (HTA) and guideline producing organisations, funding bodies, consumer groups, hearing research organisations were consulted and bibliographies from experts were obtained. Clinical effectiveness studies were selected for inclusion if they met the following criteria: (1) used either randomised prospective controlled trial or randomised cross over study designs; (2) were undertaken on a population of hearing impaired individuals; (3) involved a comparison of two or more hearing aid technologies; and (4) used either an objective laboratory hearing/speech test or a self-report disability/quality of life questionnaire. For the purposes of the specific aim of this review, a detailed data extraction was undertaken for those studies that included a comparison of analogue versus digital hearing aids. All comparative studies of hearing aids that included a cost analysis or economic evaluation were data extracted. Quality of included studies was assessed and a detailed qualitative review of the evidence presented. Results This review identified a total of eight randomised controlled and cross over trials (involving a total of 378 individuals with mild to severe hearing impairment) that address the relative effectiveness of analogue versus digital hearing aids (and for which there no outstanding queries at the time of writing). These studies were small in size and of relatively poor methodological quality. There was no difference in analogue versus digital hearing aids in terms of the objective laboratory based tests of hearing for speech (or tests of speech perception). There was evidence of benefit of digital over analogue in a number of user self-report measures, although this was not a consistent pattern either within or across studies. Across the eight studies there was only one study which reported benefit of analogue over digital in one outcome. A further 41 studies were identified which made comparisons between hearing devices and that looked at issues such as monaural vs binaural, directional microphone technology and non-linear amplification. Only three economic evaluations were identified. The first of these reported a possible range of incremental cost effectiveness ratios from US$ 59 to US$

1090 per unit gain of hearing benefit (as measured on either objective speech test or user self report measure) when comparing a digital to either linear or non-linear analogue aid. Two cost utility studies were undertaken that involved a comparison of a hearing aid versus no aid. These studies reported incremental cost per QALY ratios of $US 200 and 2,200 to 11,000 Euros respectively. Conclusion The evidence base comparing digital versus analogue hearing aids is small and of relatively poor quality. There appears to be little or no evidence from either laboratory or user-based outcomes of a clear consistent benefit of digital over analogue devices. Nevertheless the relatively small sample size of identified studies may reflect a lack of power rather than true evidence of a lack of effect. There are currently no direct head to head cost utility studies comparing digital versus analogue hearing aids. The incremental cost effectiveness of digital devices (compared to analogue devices) is highly sensitive to their incremental cost and could range from less than 10,000 to more than 20,000 per QALY. Further clinical research preferably in NHS service settings with well designed controlled trials measuring objective outcome (e.g., speech recognition) and validated measures of hearing specific quality of life is needed. There remains a need to systematically review the evidence of other technological advancements in hearing aids (such as binaural aids, directional microphones and methods of amplification).

1. INTRODUCTION 1.1 Background 1.1.1 Description of underlying health problem Hearing can be impaired due to pathology in the outer ear, middle ear, cochlea, the ascending pathways and the cortex. In adults the most common pathology associated with permanent hearing impairment is damage to the cochlea (inner ear). Conductive hearing impairment occurs when sound waves are greatly attenuated on the way to the inner ear. This can be caused by a variety of problems including build-up of earwax (cerumen), infection, fluid in the middle ear (otitis media with effusion) or a punctured eardrum. Sensorineural loss occurs when the outer and inner hair cells in the cochlea are damaged and is most frequently the result of ageing or substantial noise exposure. It is also suspected that early adulthood (e.g. 40 to 50 year olds) sensorineural impairment might a have a significant genetic component. 2.1% (95% confidence interval: 1.8% to 2.5%) of the adult population has a hearing impairment with a conductive component and 13.8% has a sensorineural impairment alone. As hearing impairment becomes more severe, the proportion with a conductive component increases. Whilst conductive hearing impairment can often be beneficially treated with medical or surgical intervention, sensorineural impairment cannot presently be reversed.1 Hearing impairment is one of the most prevalent causes of disability.2 Hearing impairment can have a profoundly negative influence on the individual, family and close associates. Reported functional disability is considerable and common. Adverse effects on physical, cognitive, emotional, behavioural and social functions, and employment status have been reported.3-5 These effects are often regarded by the hearing impaired person as representing handicap even when the degree of audiological detectable hearing loss is relatively mild. Only a small number of hearing studies have provided estimates of hearing impairment that are based on representative population samples and where impairment has been measured by standardised audiological methods3. In the UK, the current estimates of hearing impairment (and reported hearing disability) prevalence derives predominantly from the National Study of Hearing, which was conducted by the MRC Institute of Hearing Research in 19977. There are a large number of measures of hearing impairment, the most general being the hearing threshold levels obtained for pure tones at different frequencies. In order to simplify the information available and obtain an index of disability from the pattern of these thresholds over the frequency (the audiogram), an index of impairment has been used for the average hearing threshold level over the frequencies 0.5, 1, 2, and 4 kHz, in the better ear. This measure (better ear average, BEA) is probably one of the better predictors of overall hearing disability. The prevalence of BEA over a range of severity is presented in Table 1. Davis has identified that 25 Db HL, 45 Db HL and 65 Db HL levels of average impairment correspond to the median impairment of those who report mild, moderate and severe impairment respectively7. The term profound deafness is used to describe hearing loss at 90 Db HL and higher.

Table 1. Estimate of prevalence of hearing impairment as a percentage of people in the UK, aged 18-80 years, with different degrees of severity of hearing impairment in the better ear (based on 2662 people). Severity of hearing Prevalence Estimate impairment (Db HL) (95% confidence interval) 25+ 16. 1 (15.0 to 17.3) 35+ 8.2 (7.4 to 9.1) 45+ 3.9 (3.4 to 4.4) 55+ 2.1 (1.7 to 2.5) 65+ 1.1 (0.8 to 1.0) 75+ 0.7 (0.5 to 1.0) 85+ 0.4 (0.2 to 0.7) 95+ 0.2 (< 0.1 to 0.5) 105+ 0.1 (< 0.1 to 0.4) 8 Source: Davis, 1995

Recent hearing impairment estimates in England and Wales are shown in Table 2.
Table 2. Prevalence of hearing impairment by sex and age in England and Wales Sex women men both 18-64 18-64 18-64 65-79 65-79 65-79 80+ 80+ 80+ b25 b35 b65 b25 b35 b65 b25 b35 b65 1165028 1630652 510813 757995 60290 134725 1665298 1743172 1094951 921257 130949 91687 1364832 1205066 319429 595418 497272 150490 2753036 1243390 185671 3389754 2002533 223026 1967243 1706067 463376

All adults b25 4195158 3969241 All adults b35 2810829 2176524 All adults b65 510668 376903 9 Source: Davis personal communication

8110033 4951990 872073

The prevalence of hearing impairments is not greatly associated with noise exposure, gender, occupation or social class group, but predominantly with age5,7. The prevalence of hearing impairment (mild to severe) with age, is summarised in Figure 1.

Figure 1. Percentage of the population with hearing loss and the potential and actual hearing loss

100 90 80 Percentage population 70 60 50 40 30 20 10 0 18 to 40 Age group 41 to 50 51 to 60 61 to 70 71 to 80 81+

Those who have a hearing aid

Those who would benefit from a hearing aid

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All people with hearing loss

From Richards & Gleeson, 1999

Until the age of about 45 years, mild hearing problems are rare, so the prevalence estimates are small. Beyond age 50 the prevalence estimates are well over 10% approaching 50% by 70-74 years of age. It has been estimated that over the next two decades, due to increasing survival, the number of hearing-impaired people will probably rise by some 20%8. The report Childhood Deafness in the European Community puts the lower bound on hearing impairment around 1 per 1000 children with a BEA of 50Db HL born during 1969 and ascertained by 1977 (i.e. age 8 years of age) 11. This is a good benchmark to take for birth cohorts in the 1980s and 1990s8. As with adults, as the severity criterion increases the prevalence decreases so that at 65+, 80+ and 95+ Db HL the estimates were 0.74, 0.48 and 0.29 per 1000 children. 1.1.2 Current treatment options and service provision While hearing impairment may sometimes be remediated with medication or surgery if there is conductive pathology, and with the exception of cochlear implants as a surgical option only for those who have profound impairment at present, most hearing-impaired individuals are provided with a hearing aid alone to alleviate the problems with communication and orientation (but the hearing aid does not affect the underlying pathology or impairment). The benefit of wearing an aid is well established. For example, a large randomised controlled trial has reported significantly greater quality of life in those individuals wearing a hearing aid to those without an aid.3 Based on the figures in Table 2, 8.1 million individuals in England and Wales will have a hearing impairment in the better ear (i.e. 25 Db HL) of whom 2.8 million have an impairment (i.e. 45 Db HL) which confers substantial disability12. Of these approximately 1.4 million (3.4% of total population) are currently aided (in England & Wales), the proportion of which as not changed over the last 15 years. The Royal National Institute for Deaf People has

stated the need to increase the number of people who are aided and to set a target of 5.0% (i.e. 2.5 million users) so that 50% of those who could greatly benefit might be allowed to do so. The reasons for this level of unmet need are well researched and were summarised in a recent Audit Commission report4. Factors include the stigma attached to hearing loss and wearing a hearing aid, people being unaware of hearing loss (e.g. family members may compensate imperceptibly), and that GPs may not refer or may delay referral. The Medical Research Council Ear Nose & Throat (ENT) survey in1999 reported that 81% of users have NHS aids, 12% per cent have privately purchased aids, and 7% have both13. The NHS in England issues between 500,000 and 600,000 hearing aids per annum, of which approximately 220,000 are to new users and approximately 15,000 are to children.4,14 In 1997, the total NHS Audiology service cost was about 50 million per annum of which about 25 million represents the cost of hearing aids (and batteries), the remainder being staff, ENT costs (e.g. assessments) and other infrastructure. Of this 25 million, some 3.25 million (13%) is spent on hearing aids purchased outside of NHS Supplies.15 NHS hearing aid services are currently provided at 250 centres throughout the UK, which are attached mainly to ENT departments or Audiology departments of trusts. Audiology centres provide hearing aids that are purchased through NHS Supplies in over 90% of cases thus defining the NHS range of hearing aids. The specification of the current NHS range technology will be described in the next section. The average total cost of supplying an NHS hearing aid is about 90 of which about 40 is the cost of the hearing aid.14 Each year, approximately 150,000 aids are sold privately. The cost of a privately purchased hearing aid ranges from 250 to 3000.4,16 This increased cost reflects the more recent technological developments of the hearing aids dispensed privately compared to NHS aids. The recent Audit Commission report identifies a twofold variation in the provision of hearing aids between former health authority areas, and an even greater intra-regional variation. Moreover this report also described a wide variation in waiting times for hearing aid fitting across UK. The average wait for an appointment to have an aid fitted is 19 weeks, and in one-fifth of health authority areas the average wait was reported to be longer than 6 months. Finally, a number of reports have indicated that approximately one third of hearing aids are infrequently or never used. It is considered that this lack of usage is due to a combination of poor technology, inappropriate fitting and inadequate guidance and education of hearing aid users.15,17 1.1.3 Hearing aid technology current NHS provision & developments in technology A hearing aid is an electronic device consisting of a microphone, an electronic amplifier, a receiver and a battery. The microphone receives environmental sounds, the amplifier enhances a few or several frequencies (signal processing during this amplification stage can be via analogue or digital means), depending on the needs of the user, the receiver transmits the modified sounds to the middle ear, all powered by the battery. By manipulating and amplifying sound, hearing aids provide better hearing and 7

speech comprehension. There is currently a wide variety of hearing aid types available. This range of devices and their technological basis is described below in the context of current NHS provision. a. Current NHS Range The NHS range of hearing aids has been traditionally based on 1970s analogue behind the ear (BTE) technology. A basic analogue hearing aid provides the same amount of amplification, regardless of the intensity of sound entering it, so the technology is defined as linear. More recently, these devices have been updated to include some technological developments which provide non-linear amplification. These developments include compression that can involve both automatic gain control (AGC) and wide dynamic range compression (WDRC). Compression controls loudness (loud sounds are often uncomfortable to users), while still providing adequate amplification for soft sounds (which are not always heard with basic analogue devices). There is more amplification for softer sound than there is for louder sounds with compression hearing aids so that when a sound entering (or in some cases, exiting) the hearing aid reaches a critical level, the amplification of the compression hearing aid is reduced. In addition to compression, there has also been miniaturisation of analogue devices so that they can be fitted in the ear (ITE) and are therefore more cosmetically acceptable to users. It is estimated that around 50% of NHS aids remain of the basic analogue BTE design. The average total cost of fitting a NHS hearing aid is about 90, which includes an average hearing aid cost of 4016. The most expensive NHS aids (i.e. WDRC) costs 144. NHS aids are usually fitted monaurally i.e. one hearing aid per user. Currently NHS audiology service providers have discretion to make arrangements for supplying commercial (more technologically advanced) hearing aids if there is exceptional clinical need, and they are more likely to exercise this discretion if the hearing aid user is relatively young. However, the exercise of this discretion depends on local priorities and resources. b. Developments in hearing aid technology In recent years there has been a number of technological developments in hearing aid technology. These developments have included miniaturisation (i.e. ITE and completely in the canal (CIC) devices), programmability (i.e. signal processing can be selectively adjusted to suit the users needs), compression (see above), and directional enhancement (i.e. various means by which sounds in front of the hearing aid user are emphasised, and sound from other directions suppressed). Probably the single most publicised development in hearing aid technology has been the introduction of digital aids in the mid 1990s. These aids use digital (as opposed to analogue) signal processing (DSP). With digital hearing devices, the incoming analogue signals received by the microphone are sent through a preamplifier to an analogue-to-digital (A/D) converter, where the signals are converted into numerical values (i.e. zeros and ones). The numbers are then changed by the DSP unit according to a set of algorithms that is either preset or programmed by the audiologist. A new set of numerical values is produced, which is then reconverted from digital-to-analogue (D/A) as it exits the loudspeaker in the hearing aid and enters the users ear canal. Digital hearing aids have several important features potentially not available in a basic linear analogue aid, including fine-tuning frequency responses, active 8

feedback control, use of multiple and directional microphones, and background noise reduction strategies. In allowing more parameters to be adjusted to suit the individual the fitting of a DSP aid is a complex and potentially more time consuming procedure than for a conventional aid. DSP fitting requires access to computer technology and specialist software18. The potential advantages described for DSP over conventional aids include: (1) The extremely high precision with which frequency-gain characteristics can be specified and the use of this capability to study the effects. (2) The use of memory and logical operations in the implementation of adaptive paired-comparison techniques for more effective hearing aid prescription (3) The use of powerful signal processing techniques for noise reduction. (4) The use of DSP aids as generalised hearing instruments which can be used for simulation, testing and prescription, as well as amplification.19 The first commercially successful DSP aid was produced by Widex (the Senso) in 1994 closely followed by Oticons Digifocus the following year. Many manufacturers have followed this trend and now supply DSP aids. Since their arrival in the mid 1990s sales of DSP aids have grown rapidly in the private retail market and now account for some 25% of all private fittings in 1998. The average costfor a DSP aid can range from 250 to 3000, which includes an average cost of an aid of 600.4,16 Different countries have taken up DSP aids at different rates. For example, the USA is estimated to have an 82/18 split between traditional analogue and modern digital aids, of which 80% are the smaller ITE/ITC/CIC aids. However, Europe has a 65/35 split of analogue versus digital and only 30% are smaller aids with the remainder being BTE.16 At present DSP aids are not supplied within the NHS. The Royal National Institute for Deaf People (RNID) has recommended that digital aids should be standard provision within 5 years12. In summary, considerable technological developments have taken place in hearing aid technology over the last two decades with a resultant substantial increase in sophistication. The hearing aid technology that is currently available through the NHS is considerably outdated compared to the miniaturised digital aids available in the private market. Digital aids provide a more technically advanced solution to hearing impaired users than conventional analogue aids. However, the extent to which this technological advancement results in better user outcomes has yet to be fully established and is therefore the focus of this review. The following section considers how user outcomes should be measured in order to assess the comparative benefit of different hearing aids. 1.1.4 Evaluating the benefits of hearing aid developments Two key methodological factors in assessing the effectiveness of hearing aid development are study design and outcome selection. As with other healthcare interventions, the randomised controlled trial represents the gold standard when assessing clinical effectiveness of one hearing aid technology compared to another. The cross over study is a commonly used design in the area of hearing aid evaluation i.e. in the case of the comparison of hearing aids A and B, half the users are allocated to wearing hearing aid A followed by hearing aid B, while the other half are 9

allocated to wearing hearing aid B followed by A. The within individuals comparisons of a cross over design has the advantage of increasing statistical power and thereby reducing the number of users needed.20 Cross over design requires chronic stable diseases and can only study short-term effects. Evaluation of the impact of hearing aids for hearing impaired people is therefore well suited to such a study design. However, cross over designs have potential methodological problems, in particular, carry-over (i.e. the effect of hearing aid continues after the cross over period) and order (i.e. the magnitude of effect of hearing aid A will be altered if it either precedes or follows hearing aid B). In order to minimise an order effect, it is important that users are randomly allocated to hearing aid provision.21 Traditionally, much of the published research documenting hearing performance has used laboratory based objective tests of hearing/speech (i.e. electroacoustic testing). Such assessments have the advantage of objectivity, although there is also the recognition of the importance of assessing user benefit in terms of everyday living. Despite no formal consensus as to which particular categories of outcome assessment should be undertaken when assessing hearing aid benefit, a number of commentators22,23 have suggested two broad categories of outcome assessment: 1. Laboratory based tests: i.e. use of objective tests of listening/hearing that mimic situations (i.e. speech tests in quiet and noise) that are frequently encountered in everyday life; 2. Disability/quality of life measures i.e. use of validated self-report questionnaires designed to assess disability/quality of life of hearing impaired individuals e.g. Glasgow Hearing Aid Benefit Profile (GHABP), Hearing Aid Performance Inventory.22,23

1.2 Aim of Review The aim of this review is to assess the clinical and cost effectiveness of developments in hearing aid technology (in particular, digital hearing aids) in comparison to analogue hearing aids (in particular, the current NHS analogue range).

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2. METHODS An initial scoping literature search was undertaken which focussed on the identification of existing reviews and other key papers, as well as identification of randomised controlled trials and cross over trials likely to be included. Two previous systematic reviews were identified, the first being a review of effectiveness of bone anchored hearing aids (a device that does not use conventional air conduction methods) 24 and the other a review of the effectiveness of community based audiology services25. No systematic review of the comparative clinical and cost effectiveness of hearing aid devices was identified. 2.1 Search Strategy The search strategy aimed to identify randomised controlled trials, randomised cross over trials and economic studies relating to digital hearing aids. Keyword strategies were developed based on terminology and indexing terms identified from studies retrieved in the scoping search and from information disseminated by the RNID. Keyword strategies did not include terms which would restrict results to specific comparisons or to specific populations. Keyword strategies were therefore sensitive enough to retrieve studies comparing digital hearing aids with any other type of hearing aid tested on any population. Searches of the following electronic databases were undertaken; Medline, Embase, Science Citation Index (SCI), Cochrane Database of Systematic Reviews (CDSR), Cochrane Controlled Trials Register (CCTR) and the NHS Centre for Reviews and Dissemination databases (DARE, NHS EED, HTA). Date and language restrictions were not used. The keyword strategy for Medline is in Appendix 1. Keyword strategies for all other databases are available. Further searches were undertaken of current research registers (National Research Register (NRR), MRC Clinical Trials Register, Current Research in Britain (CRIB) and US National Institutes of Health (NIH) Clinical Trials Register. The publication lists and current research registers of health technology assessment (HTA) and guideline producing organisations, funding bodies, consumer groups and hearing research organisations were consulted. Bibliographies from experts were obtained. At the final stage of the review, citation searches using SCI search facility of included studies was undertaken. The reference lists of included studies were also checked. 2.2 Inclusion/exclusion criteria Studies were selected for inclusion in the clinical effectiveness section of this review if they met the following criteria: 1. used either randomised prospective controlled trial or randomised cross over study designs; 2. were undertaken on a population of hearing impaired individuals; 3. involved a comparison of two or more hearing aid technologies; 4. used either an objective laboratory hearing/speech test or a self-report disability/quality of life questionnaire.

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All comparative studies of hearing aids that were identified as including a cost analysis or economic evaluation were included within this review. Two reviewers independently undertook study inclusion/exclusion decisions based on publication abstracts. Any disagreements regarding study selection between the two reviewers were resolved by consensus. Where insufficient information was available in the abstract to make a decision, the full study paper was obtained. In situations where there remained insufficient information (e.g. study design) the authors of the paper were contacted. 2.3 Quality assessment and data extraction of included studies Detailed quality assessment and data extraction were undertaken for those studies which met the specific aim of the review i.e. for those studies where there was an explicit comparison of a digital vs analogue hearing aid. Other hearing aid comparisons which met the inclusion criteria but which did not include a direct comparison of a digital vs analogue hearing aid were categorised and listed by the nature of the comparison (e.g. digital vs digital, non-linear amplification, directional microphones etc.) 2.3.1 Quality assessment of included studies The quality of studies comparing digital to analogue devices were assessed on the basis of: 1. was there an adequate description of the method of randomisation?; 2. was there blinding (i.e. at least blinding of outcome assessment)?; 3. was there a description of study withdrawals and was a percentage follow-up of 80% or more achieved?; 4. were the study outcomes analysed by intention to treat?; 5. was a formal pre-study power calculation performed?; 6. were validated outcome measures used?26 Study quality assessment was initially undertaken by one of the reviewers (RT) and checked by the other (SP). 2.3.2 Data extraction of included studies For the purposes of the specific aim of this review, a detailed data extraction was undertaken for those studies where there was an explicit comparison of an analogue (or conventional linear) hearing aid versus a digital hearing aid. Data extraction was undertaken by one of the reviewers (RT) and checked by the other (SP). 2.4 Data analysis/presentation Given the generally poor reporting of detailed numerical results and the heterogeneity in study outcomes it was considered inappropriate to pool the results across the studies. Instead a detailed qualitative analysis was undertaken.

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Comparison of hearing aid technologies which did not include a digital vs analogue comparison are listed in Appendix 2. Studies where details of methodology were not available at the time of writing this report are listed in Appendix 3. Excluded studies are listed in Appendix 4.

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3. RESULTS 3.1 Quantity of research available The clinical effectiveness results of included studies that compare analogue hearing aids versus digital hearing aids and cost analysis/effectiveness results for all hearing aid comparisons are presented in this section. Randomised controlled trial and cross over studies of other hearing aid comparisons are listed in Appendix 2.
Table 3. Summary of study selection

Abstracts identified Abstracts meeting inclusion criteria Full papers meeting inclusion criteria Included studies by comparison: Digital vs analogue Cost Digital vs digital Directional hearing aids Mono vs binaural Non-linear Other Total * **

260 112 83

8* (12)** 8 (8) 6 (6) 9 (10) 4 (5) 19 (28) 3 (9)

57 (78) Numbers not in parentheses = studies definitely included Numbers in parentheses = studies definitely included + pending studies awaiting information from author

3.2 Assessment of clinical effectiveness A total of eight randomised controlled trials and cross over studies, comparing digital versus analogue hearing aids, were identified. Study details and results are summarised in Tables 4 and 5. Given the generally poor reporting of detailed numerical results in the trial papers and the heterogeneity of study outcomes, it was decided to report these results qualitatively. The results for each study outcome were summarised as follows: A=D A>D D>A i.e. no evidence of statistical difference in outcome between analogue and digital aid; i.e. outcome in analogue aid statistically superior (P < 0.05) to digital; i.e. outcome with digital aid is statistically superior (P < 0.05) to analogue.

3.3 Assessment of cost effectiveness A total of eight cost analysis and cost effectiveness studies were identified for review. The details and results of these studies are summarised in Table 6.

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Table 4. Study population, design, quality, intervention and comparison Author (year) Design & quality Study population Citation (N, severity, Country male/female, age) Arlinger et al, 1998 Cross over N = 33 (20 males) 27 Scand Audiol 27:51-61 (1) N randomised (2) N Mean age: 62 yrs Arlinger & Billermark, 1999 (3) C/T(?%) (19-76 yrs) 28 Br J Audiol 33:223-232 (4) C/T Experienced users (6 (5) N months to 4 yrs current Sweden (6) Y aid) Sensorineural loss? Mild to moderate hearing impairment

Digital aid (make, fitting) BTE Oticon DigiFocus Digital fitted either monaural or binaural (to match previous hearing aid experience)

Analogue (make, fitting) Own hearing aid Various BTE (18 products): 8 K-amp circuitry 5 other non-linear signal processing (ASP, AVP, input controlled AGC) 7 multiprogrammable 3 selectable uni- or omni-directional microphone Monaural or binaural fitting to match hearing aid experience

Comments

Pseudo randomisation by time i.e. first 16 patients received aids in order AB & next 17 in order BA. Patients not blinded. No information on assessor blinding.

Berninger & Karlsson, 1999 29 Scand Audiol 28:117-25 Sweden

RCT (1) N (2) C/T (3) Y (88%) (4) C/T (5) N (6) Y

N = 200 (106 males) randomised Mean age: 73 yrs (18-92 yrs) First time users Sensironeural (6% mixed) Level of hearing impairment? N=94 analogue completers N=92 digital completers

Widex Senso BTE model (C8) Or Widex CIC (CX) Digital aid.

Other aids Analogue with no restriction on choice (29 aids from 10 manufacturers used)* Monaural or binaural fitting to match hearing aid experience

* Products listed, specifications not given

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Author (year) Citation Country Bille et al., 1999 30 Scand Audiol 28: 127-35 Denmark

Design & quality

Cross over (1) N (2) Y (3) Y (89%) (4) C/T (5) N (6) Y

Boymans et al, 1999 31 Audiology 38:99-108 Netherlands

Cross over (1) N (2) N (3) C/T (4) C/T (5) N (6) Y

Study population (N, severity, male/female, age) N = 28 (10 males) randomised Median age: 71 yrs (32-89 yrs) Experienced analogue aid users Sensironeural loss Mild to severe hearing impairment 25 completers N = 27 randomised Median age: ? yrs (17-86 yrs) Experienced ITE aid users Sensironeural loss Level of hearing impairment?

Digital aid (make, fitting) Widex Senso C8 Digital aid Either binaural or monarual

Analogue (make, fitting) Widex Logo L8 & L12 Linear analogue aids Either binaural or monaural (matched)

Comments

Aids tested identical in appearance thus users blinded. Assessors not blinded.

Widex Senso Digital aid

Reference aid ITE analogue aids (19 aids from 7 manufacturers)*

Study carried out in two clinical sites. *Products listed, specifications not given but did not include multiprogrammable aids with remote control Authors contacted to confirm randomisation

Newman & Sandridge, 1998 American Journal of 32 Audiology 7:115-128 United States

Cross over (1) N (2) C/T (3) Y (100%) (4) Y (5) N (6) Y

N = 25 (13 males) randomised Mean age = 69.2 yrs (47-84 yrs) Experienced ( 1 yr) users Sensorineural loss Severity of hearing impairment?

Oticion Digifocus BTE Seven band two channel digital aid Monaural or binaural (according to previous use)

*Oticon Personic 410 or 420 **Oticon MultiFocus Compact or Compact Mild *BTE One channel linear mini analogue aid (with AGC-I input limiting (410) or with active output limiting (420)) ** BTE Two channel mini analogue aid Monaural or binaural (matched)

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Author (year) Citation Country Ricketts & Dhar, 1999 33 JAAA 10(4):180-189 United States

Design & quality

Cross over (1) N (2) C/T (3) Y (100%) (4) Y (5) N (6) Y

Study population (N, severity, male/female, age) N = 12 (? Males) randomised Median age = ? (adults) Experienced users? Sensorineural loss Mild to moderate / severe hearing impairment N = 29 (? males) randomised Mean age = ? 11 participants experienced users Sensorineural hearing loss Severity of impairment? N =20 completers N = 24 (? Males) randomised Mean age = 60 years (35 to 71 years) 12 new users, 12 experienced users Sensorineural hearing loss Severity of impairment?

Digital aid (make, fitting) Siemens Prisma with VAD or Widex Senso C8 & C9 Digital BTE Tested with directional and omnidirectional microphones

Analogue (make, fitting) Phonak Piconet PS AZ

Comments

Digitally programmable BTE analogue aid. Tested with directional and omnidirectional microphones conventional aid Various: 12 linear with peak clipping 2 output compression 6 input compression All monaural

Authors contacted to confirm randomisation Pseudorandomisation (counterbalanced) for first test condition. All other test conditions randomised

Yund et al, 1987 J Rehab Res Devpt 34 24(4):161-180 United States

Cross over (1) N (2) C/T (3) Y (69%) (4) C/T (5) N (6) Y

Experimental aid 8 channel compression with digital signal processing Monaural

Author contacted to confirm randomisation

Wesselkamp, 1999 Siemens technical report, 35 15-Mar-99 Germany

Cross over (1) N (2) C/T (3) C/T (4) C/T (5) N (6) Y

(1) Siemens Prisma Digital aid with selectable microphones 6. Ref 2 Digital aid with nondirectional microphone

* Ref 1 aid Analogue aid with selectable nondirectional / directional microphone

Siemens Prisma also compared with another digital aid (Ref 2 aid). D vs A presented only

Y = criteria met, N= criteria not met, C/T= cant tell : Quality indicators: (1) was there an adequate description of the method of randomisation?; (2) was there blinding (i.e. at least blinding of outcome assessment)?; (3) was there a description of study withdrawals and what was the percentage follow-up of 80% or more achieved; (4) were the study outcomes analysed by intention to treat; and (5) was a formal pre-study power calculation performed; (6) were validated outcomes used ?: information not provided or unclear

17

Table 5. Study outcomes, follow up period & results Author (year) Study outcomes Country Arlinger 1998 Arlinger & Billermark, 1999 Laboratory measures 1. Speech recognition in noise Self report 2. APHAB 3. Gothenburg Profile 4. Perceived sound quality 5. Preference

Period of follow-up 1 month (with each aid)

Results (at follow up) 1. A = D 2. D > A (3 subscales) 3. D > A 4. D > A or D = A 5. D > A

Comments 1 year follow up on 29 of 33 who continued to use digital (i.e. non comparative) indicated further increase in outcome 1 and maintained levels of outcomes 2 to 5. Compliance of hearing aid use, doubled compared to during the period with own aid. D > A clearness / dullness, D = A softness / sharpness Although no significant differences in outcomes 1, 2, 4 & 5, there was a trend of better outcomes for digital

Berninger & Karlsson, 1999 Laboratory measures 1. Hearing thresholds in sound field 2. Speech in competing speech Self-report 3. APHAB 4. usage Other 5. Fitting time Laboratory measures 1. Speech recognition in noise Self-report 2. Questionnaire of everyday function 3. Preference 4. Satisfaction Laboratory measures 1. Speech recognition (various situations) 2. Loudness scaling Self report 3. Questionnaire rating general aid performance 4. Preference At least 3 weeks 1. A = D 2. A = D 3. D > A (1 category) 4. A = D 5. A = D

Bille et al, 1998

6-9 weeks

1. A = D 2. A = D 3. A = D 4. A = D

Questionnaire carried out by interview. No outcome validation information provided.

Boymans et al, 1999

4 weeks

1. A = D (in general) 2. A = D 3. A = D 4. D > A

No validation information provided for questionnaire Differences between aids appeared to differ across two clinical sites. Consistent trend in improvement in questionnaire outcomes with digital.

18

Author (year) Country Newman & Sandridge, 1998

Study outcomes Laboratory measures 1. Audibility Index 2. SPIN Self report measures 3. APHAB 4. HHIE 5. Knowles Hearing Aid Satisfaction Survey 6. Hearing daily use log 7. Preference rating Laboratory measures 1. speech recognition (in anechoic and typical living room conditions)

Period of follow-up At least 4 weeks

Results (at follow up) 1. 2. 3. 4. 5. 6. 7. A = D or A > D* D>A A=D A=D A=D A=D 7. A = D or A > D

Comments Digital vs analogues differences reported * No difference at 50dBHL but difference at 80dbHL A = D (cost of HAs not revealed) but A > D (cost of HAs revealed)

Ricketts & Dhar, 1999

None

1. A = D*

Testing undertaken in the laboratory setting with no period of field familiarisation. *Directional microphone > omnidirectional microphone whether digital or analogue in all test conditions Testing undertaken in the laboratory setting with no period of field familiarisation.

Yund et al, 1987

Laboratory measures 1. Signal to noise ratios at two noise levels Laboratory measures 1. Speech in quiet 2. Speech in noise Self report measure 3. Sound quality rating

None

1. A = D

Wesselkamp, 1999

4 weeks

1. A = D 2. D > A or A = D* 3. D > A

*D > A in directional microphone mode, D = A (or A > D?) in non-directional mode

19

Table 6. Summary of cost analyses and economic evaluations Author (year) Type of study Source of data Hearing aid Citation, Country comparisons Davis et al, 1995 MRC internal 14 report United Kingdom Lamden et al, 1995 J Public Health 36 Med 17:445-9 United Kingdom Cost analysis 1993 survey of all hearing aid clinics (198) in England & Wales Observational on 50 randomly selected users Single hospital in England June-Sept 1992 Randomised cross over study 25 users NHS range

Costs

Benefits

Cost effectiveness ratios

Comments

1. 92.90 per aid

Cost includes fitting & overheads (25%)

Cost analysis

NHS range (monaural)

1. 25 aid 2. 13 clinic attendance for follow up

Newman & Sanderbridge, 1998 Am J Audiol 7:11532 128 United States

Cost effectiveness analysis

A: linear analogue B: non-linear analogue C: digital

A: $1192 B: $1660 C: $3732

SPIN & HHIE Outcomes *

A: $49.67 to 98.51 B: $51.88 to $112.16 C: $109.76 to $223.47 AvsB: $58.5 to $173.33 BvsC: $1036.00 to $1090.00 AvsC: $254.00 to $552.17

All costs in US$ See Table 1 for further details *Selected outcome which show benefit

Parving et al (1997) Scand Audiol 37 26:231-9 Denmark

Cost analysis

Randomised cross over trial 44 users

A: Resound Programmable WDRC (Upto-date aid) B: Linear/nonlinear BTE (Traditional aid)

A: 450 B: 270 Additional fitting costs of B over A: 150*

* includes fitting equipment & staff time

20

Author (year) Citation, Country Joore (1999) EHIMA Conference 38 paper Netherlands

Type of study

Source of data

Hearing aid comparisons Hearing aid vs no aid

Costs

Benefits

Cost utility analysis

1. Costs from a modelling of current Dutch hearing aid provision 2. HRQOL Utility assessment from pre-post study on 60 users over 16 weeks Randomised controlled trial 194 users

Total cost of aid: 1295 Euros (includes GP referral, ENT specialist, Audiology centre & cost of aid)

Utility gain: EuroQol: 0.04-0.21 (CI?) Hearing aid QOL: 0.19 (95% CI 0.04? to 0.21)

Cost effectiveness ratios Cost per QALY 2,200 to 11,000 Euros

Comments

Assumes average life span of aid of 2.5 yrs Discounting rate: 5% 1.00 =1.54 Euros

Mulrow et al, 1990 Ann Intern Med 3 113:188-194 United States

Cost utility analysis

Analogue vs no aid

Total cost of aid: US$ 1000 (includes testing, fitting, and one follow up evaluation) Lab test of sound quality

Cost per QALY* US$200

*based on percent improvements in HHIE

Palmer et al, 1995 Ear & Hearing 39 16:587-598 United States Reeves et al, 2000 Health Techol 25 Assess 4(4) United Kingdom

Willingness to pay

Controlled trial (Randomised?) 11 users

Comparison of 2 aids (details of aids not clear)

$6.75 per percentage point improvement in speech quality

Users asked to make dollar value judgements on sound quality

Cost analysis

Systematic review of 11 studies of community audiology provision. (published 1981 to 1997)

BTE & ITE NHS aids

New hearing aid: 35.00 Accessories: 3.05 Exchange of hearing aid: 17.50 Ear mould: 6.00 Community clinic per attendance: 10.29 Hospital clinic per attendance: 8.69

21

4. DISCUSSION 4.1 Clinical Effectiveness This review identified a total of eight randomised controlled trials including cross over studies (involving a total of 378 individuals with mild to severe hearing impairment) that address the primary focus of this review i.e. the relative effectiveness of analogue versus digital hearing aids. These studies are small in size (on average 47 individuals) and of relatively poor methodological quality. In none of the studies was the method of randomisation described or a formal pre-study sample size calculation reported. The different physical characteristics of the hearing aid devices make user and clinician blinding difficult. Nevertheless blinding of outcome assessment is both possible and potentially important in order to reduce bias associated with laboratory based audiological testing. None of the studies reported that the assessors were blinded. Across these eight studies there appeared to be no difference in analogue versus digital hearing aids in terms of objective laboratory based tests of hearing. Although there was evidence of benefit of digital over analogue devices in a number of user self-report measures, this was not a consistent pattern either within or across studies. Across the eight studies,only one study reported benefit of analogue over digital in one outcome. There are number of methodological issues that need to be considered in interpreting these studies. Firstly, given the relatively small sample size of these studies, findings of no difference may simply reflect the lack of power of the study rather a true lack of difference. However the two studies with the largest sample sizes (75 or over) both reported no difference between analogue and digital across all outcomes. Second, although most of the studies used validated outcomes it remains possible that these outcomes lack the sensitivity to detect the true underlying differences that might exist between these devices. Third, in these studies, the period of familiarisation with each device ranged from 0 to 9 weeks. It may be that such a period of time is insufficient to allow the users to fully adapt and therefore benefit from the hearing device. In the case of the study by Arlinger and Billermark, an additional 12-month follow up was undertaken at which they reported an increased level of speech recognition ability compared to that at 1 month. Fourthly, although in most cases the details of the comparator analogue aids was inadequately reported, the analogue devices used across the majority of these studies generally appeared to be more sophisticated than a conventional linear (NHS type) device. It therefore remains plausible that a more consistent pattern of improvement might have been observed if the digital devices had been compared with conventional linear analogue aids in these studies. Finally, the interpretation of the findings of the comparisons undertaken by these studies cannot simply be interpreted on the basis of analogue versus digital signal processing alone. For instance the study by Ricketts and Dhar demonstrated no difference between digital and analogue devices in terms of signal processing (i.e. a digital versus analogue comparison).33 However, there was significant benefit of directional versus omnidirectional microphones in all listening conditions irrespective of the whether the aid was digital or 22

analogue. A full interpretation of the potential benefits of recent hearing aid developments is therefore also dependent upon the review of the of the evidence comparing the range of hearing aid technological developments, such as binaural fitting, directional microphones and methods of amplification (see Appendix 2). To date, no systematic review of these other technological comparisons has been undertaken.

4.2 Cost Effectiveness Although a number of cost studies are reported in this review only three economic evaluations (i.e. comparison of both costs and consequences) were identified. The study of Newman and colleagues report in 1998 a possible range of incremental cost effectiveness ratios from US$ 58.50 to US$ 1090.00 per unit gain of hearing benefit (as measured by either objective speech test or user self report measure) when comparing a digital to either a linear or nonlinear analogue aid. The hearing specific nature of the outcome makes interpretation (and comparison to other health care interventions) difficult. Two cost utility studies were identified that involved a comparison of an hearing aid versus no aid. The study by Mulrow and colleagues reported an incremental cost per QALY ratio of $US 200 for the analogue aid. No incremental utility scores were reported in this study. Joore reported a range of incremental quality of life utility gain with a hearing aid of 4 to 21 percentage points. This range corresponds to an incremental cost per QALY of 2,200 to 11,000 Euros. Although the incremental cost utility ratios of both these studies appear to be low, within the range usually considered to be acceptable within the NHS, these figures do not address the relevant comparison (i.e. digital vs analogue) in the context of this review. Given both the greater costs of the digital devices and their relatively small benefit in terms of clinical effectiveness in comparison to analogue aids (see Table 5), the incremental cost effectiveness of digital versus analogue hearing devices could be considerable. As described earlier in this report the private cost of a digital hearing aid may be as high as 3,00016 (i.e. 2,910 more than a current NHS analogue device). However, in the volume market of the NHS, the unit costs are likely to be considerably less. Two manufacturers have indicated in their submissions that the extra cost of introducing digital devices into the NHS is likely to be 250. Table 7 illustrates the gains in quality of life that digital hearing aids would need to achieve in order to reach various incremental cost effectiveness ratios, under a range of assumptions about the incremental cost and expected life of digital aids. This what-if analysis implies, for example, that at an additional cost of 250 a digital aid would need to achieve a 1.3 percentage point (or more) gain in quality of life (relative to an analogue aid) in order to attain an incremental cost effectiveness ratio of 10,000 per QALY (or less), assuming a 2 year hearing aid life. For the same incremental cost per QALY ratio, a digital aid with an additional cost of 3,000 and an expected life of 2 years, would need to achieve a gain in quality of life of 15 percentage points. To achieve an incremental cost effectivenes ratio of 20,000 per QALY, a digital hearing aid costing an additional 250 compared to an analogue aid, and with an expected life of 2 years, would only have to achieve a 0.6 percentage point

23

improvement in quality of life. This simple analysis illustrates the sensitivity of the incremental cost-effectiveness ratio to the cost of digital aids, the expected life of aids, and to the mean gains in quality of life.
Table 7. Gains inquality of life required to achieve various incremental cost effectiveness ratios as a function of the incremental cost of a digital device (versus analogue) and the life time of the device. Expected Incremental cost-effectiveness ratio (/QALY) Incremental life of aid 1 cost () (years) 5,000 10,000 20,000 50,000 50 1 0.010 0.005 0.003 0.001 50 2 0.005 0.003 0.001 0.001 50 5 0.002 0.001 0.001 0.000 100 1 0.020 0.010 0.005 0.002 100 2 0.010 0.005 0.003 0.001 100 5 0.004 0.002 0.001 0.000 250 1 0.050 0.025 0.013 0.005 250 2 0.025 0.013 0.006 0.003 250 5 0.010 0.005 0.003 0.001 1000 1 0.200 0.100 0.050 0.020 1000 2 0.100 0.050 0.025 0.010 1000 5 0.040 0.020 0.010 0.004 3000 1 0.600 0.300 0.150 0.060 3000 2 0.300 0.150 0.075 0.030 3000 5 0.120 0.060 0.030 0.012 Notes: 1. Incremental cost includes the additional cost of a digital device versus an analogue device. The incremental cost does not include potential differences between device in terms of fitting, overheads and maintenance. No discounting of costs or benefits was undertaken. This was based on the assumption that the majority of costs will be incurred in the first year of the aid (so that discounting of costs is not necessary), and that discounting of QALYs would make little difference to the above estimates. With discounting at 1.5% pa (the current UK recommended rate for non-monetary outcomes) over five years (the maximum expected life of an aid) the gains in health related quality of life would have to be about 3% greater than the above estimates.

4.3 Current research The NHS in March 2000 announced the launch of the Modernising Hearing Aids First Wave, a 4 million project to support 20 sites that will evaluate digital hearing aids. The main objectives of the project are to analyse the costs and efficacy of digital hearing aids, determine efficient and effective methods to distribute hearing aids, and to develop a modern hearing aid services for NHS users. NHS Trust have been invited to submit proposals to take part in the project, the sites are expected to be chosen in May 2000.40 The RNID is currently funding an academic group at the University of Southampton to undertake an evaluation of the relative benefits of typical NHS amplification and advanced digital devices. This study involves a cross over trial where120 hearing impaired individuals are psuedo-randomised to one of three digital devices or an NHS analogue aid. This study has been powered for a within subject digital versus analogue comparison. Both laboratory and validated user self-report outcomes are being assessed. This

24

study is due to fully report in October 2000. No results were available at the time of preparing this report.41

5. CONCLUSION The evidence base comparing digital versus analogue hearing aids is small and of relatively poor quality. There appears to be little or no evidence from either laboratory or user-based outcomes of a consistent benefit of digital over analogue devices. There are currently no direct head to head cost utility studies comparing digital versus analogue hearing aids. The incremental cost per QALY of digital (compared to analogue aids) is highly sensitive to their incremental cost. Further clinical research with well designed controlled trials measuring objective outcome (e.g., speech recognition), validated measures of hearing specific quality of life and costs, is needed. The specific aim of this review was to assess the effectiveness and cost effectiveness of digital compared to analogue hearing devices. There remains a need to systematically review the evidence of other technological advancements (such as binaural aids, directional microphones and methods amplification) in hearing aids that have also taken place in recent years.

25

REFERENCES 1. Klein AJ, Weber PC. Hearing aids. Med Clin North Am. 1999 Jan;83(1):139-51. 2. Davis AC. Epidemiology of hearing disorders. In: Kerr AG (ed.) Scott Brownss Otolaryngology. Boston: Butterworth-Heineman, 1997. 3. Mulrow CD, Aguilar C, Endicott JE et al. Quality of life changes and hearing impairment: a randomised controlled trial. Intern Intern Med 1990;113:188-94 4. Audit Commission. Fully Equipped: the provision of equipment to older or disabled people by the NHS and social services in England and Wales. Audit Com mission Report, March 2000. 5. Appolino I, Caraballese C, Frattola L et al. Effects of sensory aids on the quality of life and mortality of elderly people: a multivariate analysis. Age & Ageing 1996;25:89-96. 6. Wilson DH, Walsh PG, Sanchez L et al, The epidemiology of hearing impairment in an Australian population Int J Epidemiol 1999;28:247-52 7. Davis AC, The prevalence of hearing impairment and reported hearing disability among adults in Great Britain. Int J Epidemiol 1989;18:911-17 8. Davis A, Prevalence of Deafness. In: Hearing in Adults. Whurr, 1995. 9. Davis A. (01 May 2000). [e-mail to R. Taylor], [Online]. 10. Richards A & Gleeson M. Recent advances in otolaryngology. BMJ 1999;319:1110-3. 11. Martin et al. Childhood Deafness in European Community. 1981 12. Royal National Institute for Deaf People. Waiting to Hear, RNID, 1999. 13. The Medical Research Council. Ear Nose & Throat Survey. 1999. 14. Davis A, Spencer H, Paulson J. Cost of implications in setting a target for hearing aids provision in England &Wales. Report of MRC Institute of Hearing Research, 1995 15. Davis A. Survey of Hearing Aid Provision in England in 1997. MRC Institute of Hearing Research, 1999 16. NHS Supplies Authority. Hearing aid technology and the NHS a briefing document to the National Institute for Clinical Excellence, August 1999

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17. Turner CW, Humes LE, Bentler RA et al. A review of past research on changes in hearing aid benefit over time. J Am Acad Audiol 1998;9:16571. 18. Westermann S, Sandlin R. Digital signal processing: benefits and expectations. Hear Rev High Performance Hearing Solutions. 1999;2:5659. 19. Levitt H, Neuman A, Sullivan J. Studies with digital hearing aids. Acta Otolaryng Suppl 1990 469:57-69 20. Hills M & Armitage P. The two-period cross-over clinical trial Brit J Pharmacol 1979;8:7-20 21. Green R, Day S, Bamford J. A comparative judgement for 4 hearing aid selection procedures. 2 Quality judgements as measures of benefit. Brit J Audiol 1989;23:201-6. 22. Walden BE. Towards a model of clinical-trials for substantiating hearing aid user-benefit. Amer J Audiol 1997;6:13-24. 23. Gatehouse S. Outcomes measures for the evaluation of adult hearing fittings and service: scientific and technical report. Report to the Department of Health, November 1997. 24. Tomlinson J, Sutton J, Cooper NJ. The use of bone anchored hearing aids. Trent Institute for Health Services Research, December 1997. 25. Reeves DJ, Alborz A, Hickson FS, Bamford JM. Community provision of hearing aids and related audiology services. Health Technol Assess 2000;4(4). 26. Pocock SJ. Clinical Trials: A Practical Approach. Chicester, Wlley, 1983 27. Arlinger A, Billermark E, Oberg M et al. Clinical of a digital hearing aid. Scand Audiol 1998; 27:51-61 28. Arlinger A & Billermark E. One year follow-up of users of a digital hearing aid. Br J Audiol 1999;33:223-232 29. Berninger E & Karlsson KK. Clinical study of Widex Senso on first-time hearing aid users. Scand Audiol 1999;28:117-25 30. Bille M, Jensen A-M, Kjoerbol E et al. Clinical study of a digital vs an analogue hearing aid. Scand Audiol 1999;28:127-35 31. Boymans M, Dreschler WA, Schoneveld P et al. Clinical evaluation of a full-digital in-the-ear hearing instrument. Audiology 199;38:99-108

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32. Newman CW & Sandridge SA. Benefit from, satisfaction with, and costeffectiveness of three different hearing aid technologies. Am J Audiol 1998;7:115-128. 33. Ricketts T, Dhar S. Comparison of performance across three directional hearing aids. J Am Acad Audiol 1999;10:180-189. 34. Yund EW, Simon HJ, et al. Speech discrimination with an 8-channel compression hearing aid and conventional aids in background of speech-band noise. J Rehab Res Dev 1987;24(4):161-180. 35. Wesselkamp, M. Clinical study of PRISMA BTE at the University of Linkping. (Siemens technical report 15-Mar-99). 1999 36. Lamden KH, St Leger AS, Raveglia J. Heading aids: value for money and health gain. J Public Health Med 1995;17:445-9 37. Parving A, Sorup Sorensen M, Carver K et al (1997). Hearing instruments and health technology an evaluation. Scand Audiol 997;26:231-9 38. Joore M. Hearing aid fitting in hearing-impaired adults proves to be a very cost-effective intervention. Oral presentation to EHIMA The World of Hearing Conference, May27th-28th 1999, Brussels. (http:///www.ehima.com/program.htm) 39. Palmer CV, Killion MC, Wilber LA et al. Comparison of two hearing aid receiver-amplifier combinations using sound quality judgements. Ear & Hearing 1995;16:587-598 40. Department of Health. Measures announced to improve disability equipment services. Press release. 29th March 2000. 41. Lutman M. Evaluation of the relative benefits of typical NHS amplification and advanced digital devices [Study protocol]. Provide by RNID in their submission to the National Institute for Clinical Excellence. .

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Appendix 1. Search strategies for Medline

MEDLINE search strategy (using OVID BIOMED) 19661 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 widex.tw. senso.tw. oticon.tw. digilife.tw. digifocus.tw. prisma.tw. d series.tw. bernafon.tw. dualine.tw. starkey.tw. cetera.tw. resound.tw. ic4.tw. ensoniq.tw. digital$.tw. bone anchor$.tw. baha.tw. programable.tw. programmable.tw. wideband.tw. wide band.tw. non linear.tw. nonlinear.tw. signal process$.tw. dsp.tw. wide dynamic range compression.tw. wdrc.tw. or/1-27 Hearing aids/ hearing aid$.tw. hearing device$.tw. hearing instrument$.tw. or/29-32 exp Hearing disorders/ Rehabilitation of hearing impaired/ 34 or 35 Equipment design/ is.fs. 37 or 38 36 and 39 28 and 33 28 and 40 41 or 42 limit 43 to clinical trial Cross-over studies/ 43 and 45 44 or 46 Economics/ exp "Costs and cost analysis"/ Economic value of life/ exp Economics, hospital/ exp Economics, medical/ Economics, nursing/ exp models, economic/ Economics, pharmaceutical/

56 57 58 59 60 61 62 63

exp "Fees and charges"/ exp Budgets/ ec.fs. (cost or costs or costed or costly or costing$).tw. (economic$ or pharmacoeconomic$ or price$ or pricing).tw. or/48-60 43 and 61 47 or 62

Appendix 2. Other comparisons 1. Non-linear amplification

Reference Biering-Sorensen M et al. A clinical comparative investigation of a non-linear versus linear hearing aid. Scand Audiol 1994;24:125-132. Parving A. Comparative Investigation of Multifocus and Oticon E35F. Oticon Internal report, 1993. Nature of comparison Oticon Multifocus (non-linear) vs Oticon E35F (linear) (Behind the ear aids)

Franck BAM, Sidonne C, et al. Evaluation of spectral enhancement in hearing aids, combined with phonemic compression. J. Acoust. Soc Am 1999;106(3):1452-1464.

Spectral enhancement with compression vs spectral enhancement without compression

Hawkins DB. Naidoo SV. Comparison of sound quality and clarity with asymmetrical peak clipping and output limiting compression. J Am Acad Audiol. 1193;4(4):221-8.

Peak clipping vs output limiting compression (Behind the ear hearing aids)

Humes LE, Christensen LA, Bess FH, Hedley-Williams A. A comparison of the benefit provided by well-fit linear hearing aids and instruments with automatic reductions of low-frequency gain. J of Sp, Lang & Hear Res 1997;40(3):666-85

Linear amplification vs BILL (base increase at low levels) processing (Dahlberg in the canal hearing aid with experimental BILL circuit fitted binaurally)

Jenstad LM, Seewald RC, Cornelisse L, Shantz J. Comparison of linear gain and wide dynamic range compression hearing aid circuits : aided speech perception measures. Ear & Hearing 1999;20:117-126.

Linear amplification vs single channel wide dynamic range compression (Siemens Viva 2Pro behind the ear hearing aid fitted monoaurally)

Lundh, P. Field-test for the two channel hearing aid with compressor in low frequency channel. (Internal report 14-8-7) .Oticon Research Unit, 1983

Low frequency compression vs no low frequency compression

(Emulation of BTE Oticon Multifocus with and without low frequency compression)

Lutman ME, Payne E. Comparison of alternative compression strategies in new and experienced hearing-aid users. Institute of Sound and Vibration Research, University of Southampton, 1999, (ISVR Contract Report ; 99/31)

Multifocus compression vs wide dynamic range compression (Oticon DigiLife digital hearing aid)

Moore BCJ, Glasberg BR, et al. Optimization of a slow-acting automatic gain control system for use in hearing aids.Br J Audiol 1991;25:171-182.

Prototype dual front end automatic gain control (AGC) system vs commercially available behind the ear hearing aid with adaptable compression vs linear amplification Three configurations of a prototype dual front automatic gain control (AGC) system vs dual channel AGC system vs linear amplification

Moore BCJ, Glasberg BR. A comparison of four methods of implementing automatic gain control (AGC) in hearing aids. Br J Audiol 1988;22:93-104.

Neuman AC, Bakke MH, et al. Effect of compression ratio in a slow-acting compression hearing aid: paired -comparison judgements of quality. J Acoust Soc Am 1994;96(3):1471-1478. Neuman AC, Bakke MH, et al. Effect of release time in compression hearing aids: paired- comparison judgements of quality. J. Acoust Soc Am 1995;98(6):3182-7.

Comparison of various compression algorithms (Computer simulated digital compression hearing aid)

Niklasson-Lovbacka K. Speech intelligibility and sound quality with frequency dependent in AGC noise. Gothenberg School of Rehabilitation, 1993

Automatic gain control (AGC) vs no AGC comparing three hearing aids (Single channel BTE with K-amp circuit, two channel hearing aid, conventional hearing with linear amplification)

Nilsson P, Vesterager V, Sibelle P, Sieck L, Christensen B. A double-blind cross-over study of a non-linear hearing aid. Audiology, 1997;36(6):325-38.

Compression (K-amp circuit) vs linear amplification (Rexton Setinette circuit)

(Using in the ear hearing aids)

Parving A, Sorensen MS, Carver K, Christensen B, Sibelle P, Vesterager V. Hearing instruments and health technology--an evaluation. Scand Audiol 1997;26(4):231-9.

Subjects' own hearing aid vs programmable full-dynamic range compression (with compression) vs programmable full-dynamic range compression (linear mode) (Using behind the ear hearing aids)

Riko K, Pichor-Fuller MK, et al. Clinical evaluation of a two-channel amplitude compression hearing aid. Laryngoscope 1986;96:1226-1130.

Single channel vs two channel compression (Behind the ear hearing aids)

Sammeth CA, Tetzeli M, et al. Consonant recognition performance of hearing-impaired listeners using one linear and three nonlinear hearing aids. J Am Acad Audiol 1996;7:240-250.

Linear amplification (Argosy Linear Plus) vs three types of nonlinear amplification (2 types of BILL processing (Argosy Manhattan II with experimental modifications, Expander), peak clipping (Infinite Amplitude Clipper) (Behind the ear hearing aids under in the ear frequency conditions)

Stone MA, Moore BCJ, Alcantara JI, Glasberg BR. Comparison of different forms of compression using wearable digital hearing aids. J Acoust Soc Am. 1999;106(6):3603-3619

High frequency compression with automatic gain control (compression ratio 10:1) vs wide dynamic gain control (compression ration 2:1) vs linear amplification

Stone MA, Moore BCJ, et al. Effects of fast-acting high frequency compression on the intelligibility of speech in steady and fluctuating background sounds. Br J Audiol 1997;31:257-273

Automatic gain control (AGC) (compression ratio high) vs automatic gain control (compression ratio low) vs full dynamic range compression (FDRC) vs AGC (low) + FDRC (Audiologic Audallion digital hearing aid)

Valente M, Sammeth CA, Potts LG et al. Differences in performance between Oticon Multifocus Compact and ReSound BT2-E hearing aids. Am Acad Audiol 1997;8:280-93

Oticon Multifocus vs ReSound BT2-E (Digitally programmable analogue hearing aids fitted binaurally)

Yund EW, Buckles KM. Discrimination of multichannel-compressed speech in noise - long-term learning in hearing-impaired subjects. Ear Hear, 1995;16(4):417-427. Yund EW, Buckles KM. Enhanced speech perception at low signal-to-noise ratios with multichannel compression hearing aids. J. Acoust Soc. Am 1995;97(2):1224-1240. Yund EW, Buckles KM. Multichannel compression hearing aids: effect of number of channels on speech discrimination in noise. J. Acoust Soc Am 1995;97(2):1206-1223.

Multichannel compression vs linear amplification

Can include digital vs digital or analogue vs analogue comparisons

2. Monoaural vs binaural comparisons

Reference Balfour PB, Hawkins DB. A comparison of sound quality judgments for monaural and binaural hearing aid processed stimuli. Ear Hear 1992;13(5):331-339. Nature of comparison Comparison using Phonic Ear 805CD2 hearing aid with omindirectional microphone

Festen JM, Plomp R. Speech-reception thresholds in noise with one and two hearing aids. J. Acoust. Soc. Am 1986;79(2):465-471.

With hearing aid vs hearing aid left ear vs hearing aid right ear vs hearing aid both ears (Subjects' own hearing aids)

Hawkins DB, Yacullo WS. Signal-to-noise ratio advantage of binaural hearing aids and directional microphones under different levels of reverberation. J Speech Hear Dis 1984;49:278-286.

Monaural vs binaural using both omnidirectional and directional microphone conditions

Schreurs KK, Olsen WO. Comparison of monaural and binaural hearing aid use on a trial period basis. Ear Heari 1985, 6(4): 198-202.

Field test

Can include digital vs digital or analogue vs analogue comparisons 3. Digital vs digital comparisons
Reference Knebel S, Bentler R. Comparison of two digital hearing aids. Ear Hear 1998;19(4):280-289. Nature of comparison Oticon Digifocus vs Widex Senso

Naylor, G E60-DYN5 vs MultiFocus Compact Field Test Oticon Electronics A/S Research Unit, 1997

Oticon E60-DYN5 behind the ear (forerunner to Oticon Digifocus) vs Oticon MultiFocus Compact

Naylor, G E63 SKI field test Oticon, 1997

Comparison of two alternative SKI rationales (Used with subjects' own digital hearing aids)

Ricketts TA. Bentler RA. Comparison of two digitally programmable hearing aids. Journal of the American Academy of Audiology. 1992;3(2):101-12.

Widex Quattro vs Ensoniq Sound Selector

Warland A, Tvete O, Arntzen O, Traeland G, Skogstad W, Slethei K. Cited in News from Oticon, January 1998.

Oticon Digifocus vs Widex Senso

Wesselkamp, M. Clinical study of PRISMA BTE at the University of Linkping. (Siemens technical report 15-Mar-99). 1999

Siemens PRISMA vs Ref 2 aid (with digital signal processing and nondirectional microphone) (Also compares digital aid (PRISMA) vs analogue aid (Ref 1 aid). Included in digital vs analogue comparisons in this review)

Comparisons of two or more digital devices

4. Directional microphone comparisons

Reference Gravel J, Fausel N, Liskow C, Chobot J. Childrens speech recognition in noise using omnidirectional and dual-microphone hearing aid technology. Ear Hear 1999;20:1-11. Nature of comparison Omnidirectional microphone vs dual microphone (Phonak PiCS 332x worn binaurally in omnidirectional and dual (AutoZoom) conditions)

Hawkins DB, Yacullo WS. Signal-to-noise ratio advantage of binaural hearing aids and directional microphones under different levels of reverberation. J Speech Hear Dis 1984;49:278-286.

Monaural vs binaural using both omnidirectional and directional microphone conditions

Humes L and Bentler R. Siemens Prisma clinical trial. 1998

Omnidirectional vs directional microphone (Siemens Prisma in with and without voice activity detection (VAD) mode)

Mueller HG, Johnson RM. The effects of various front-to-back ratios on the performance of directional microphone hearing aids. J Amer Audiol Soc 1979;5:30-34.

Four directional microphone hearing aids with different front to back ratios

Nielsen HB, Ludvigsen C. Effects of hearing aids with directional microphones in different acoustic environments. Scand Audiol 1978;7:217224.

Directional vs 'coventional' hearing aid (Oticon behind the ear 568 worn binaurally with directional and conventional microphone)

Nielsen HBA Comparison between hearing aids with a directional microphone and hearing aids with a conventional microphone. Scand Audiol 1973;2:173-.

Directional (Danavox 735 DV) vs omnidirectional (Danavox 735 V) hearing aids

Sung GS, Sung RJ, Angelelli RM. Directional microphone in hearing aids. Arch Otolaryng 1975;101:316-319.

Amount of directionality between three directional hearing aids (Behind the ear hearing aids)

Valente M, Fabry D, Potts L. Recognition of speech in noise with hearing aids using dual microphones. J Amer Acad Audiol 1995;6:440-449.

Directional vs omnidirectional microphones (using 'basic' and 'party' hearing aid programmes) (Phonak PiCS in conventional and AudioZoom conditions)

Voss T Clinical evaluation of multi-microphone hearing instruments. Hear Rev 1997;4(9):36,45-46,74.

Directional vs omnidirectional microphones (using 'basic' and 'party' hearing aid programmes) (Phonak PiCS in conventional and AudioZoom conditions)

Can include digital vs digital or analogue vs analogue comparisons

5. Other comparisons
Reference Jerger J. Chmiel R. Florin E. Pirozzolo F. Wilson N. Comparison of conventional amplification and an assistive listening device in elderly persons. Ear Heari. 1996;17(6):490-504. Nature of comparison Hearing aid (Siemens Triton 3000 or 3M Memory Mate hearing aid worn monaurally) vs assistive listening device (Comtek Personal FM System)

Mulrow CD, Aguilar C, Endicott JE, Tuley MR, Velez R, Charlip WS, Rhodes MC, Hill JA, NeNino LA. Quality-of-life changes and hearing impairment, a randomized trial. Ann Int Med 1990;113:118-194

Hearing aid vs no hearing aid

Pumford J, Seewald R, Scollie S, Jenstad L Speech recognition with in-theear and behind-the-ear dual-microphone hearing instruments. J Amer Acad Audiol 2000;11(1):23-35.

Behind the ear hearing aid with dual microphone (Phonak PiCS AudioZoom) vs in the ear hearing aids with dual microphone (Phonak PiCS MicroZoom)

Can include digital vs digital or analogue vs analogue comparisons

Appendix 3: Awaiting further information from authors/manufacturers

1. Digital vs analogue comparisons Dillier N, Frolich T, Kompis M, Bogli H, Waikong L. Digital signal processing (DSP) applications for multiband loudness correction digital hearing aids and cochlear implants. J Rehab Res 1993;30(1): 95-109. Henningsen LB, Dyrlund O, Bisgaard N, Brink B. Digital Feedback Suppression (DFS) - clinical-experiences when fitting a DFS hearing instrument on children. Scand Audiol 1994;23(2):117-122 Kuk FK, Kollofski C, Brown S Melum A, Rosenthal A. Use of a digital hearing aid with directional microphones in school-aged children. J Am Acad Audiol. 1999;10(10):535-48. Lee LM at al. Hear Rev 1998;5(8):30-32

2. Non-linear amplification comparisons Barker B, Dillon H. Client preferences for compression threshold in singlechannel wide dynamic range compression hearing aids. Ear Hear 1999;20:127-139. Benson D. Clark TM. Johnson JS. Patient experiences with multiband full dynamic range compression. Ear Hear 1992;13(5):320-30 Dreschler WA. Phoneme perception via hearing aids with and without compression and the role of temporal resolution. Audiology 1989;28:49-60. Larson VD et al. The NIDCD/VA hearing aid clinical trial : a multi-center double masked study of hearing aid benefit. (Unpublished) Lippmann RP, Braida LD, et al. Study of multichannel amplitude compression and linear amplification for persons with sensorineural hearing loss. J. Acoust. Soc Am 1981;69(2):524-535. Lunner T, Hellgren J, Arlinger S, Elberling C. . A digital filterbank hearing aid: predicting user preference and performance for two signal processing algorithms. Ear Hear 1997;18(5):12-25. Lunner T, Hellgren J, Arlinger S, Elberling C. A digital filterbank hearing aid: three digital signal processing algorithms-User preference and performance. Ear Hear 1997;18(5):373-387. Lunner T, Hellgren J, Arlinger S, Elberling C. Nonlinear signal processing in digital hearing aids. Scand Audiol 27 1998;(Suppl 49):40-49.

Moore BCJ. Design and evaluation of a two-channel compression hearing aid. J Rehab Res Devpt 1987;24(4):181-192.

3. Monaural vs binaural comparisons Day GA. Browning GG. Gatehouse S. Benefit from binaural hearing aids in individuals with a severe hearing impairment. Br J Audiol.1988;22(4):273-7

4. Directional hearing aids Wouters J, Litiere L, et al. Speech intelligibility in noisy environments with one-and two-microphone hearing aids. Audiology 1999; 38: 91-98.

5. Other comparisons French-St. George M, Engebretson AM, OConnell M. Behavioral assessment of CIDs benchtop (Version 2) digital hearing aid: noise reduction. J Amer Acad Audiol 1992;3:132-141. Harrowven R A double-blind cross-over study of high frequency emphasis hearing aids in individuals with noise-induced hearing loss Br J Audiol 1987;21(3):209-19 Kelsa I, Gottlieb B, et al. Bascut hearing aids compared with standard hearing aids in patients with high-tone loss. Scand Audiol Suppl 1971;1:49Ringdahl A, Eriksson-Mangold M, Israelsson B, Lindkvist A, Mangold S. Clinical trials with a programmable hearing aid set for various listening environments. Br J Audiol 1990;24(4):235-42. Turk R. A Clinical comparison between behind-the-ear and in-the -ear hearing aids. Audiological Acoustics 1986;25:76-86. Verschuure J, Benthem PPGV, Effect of hearing aids on speech perception in noisy situations. Audiology 1992;31:205-221.

Appendix 4: Excluded studies (failed to meet review inclusion/exclusion criteria) Agnew J. Digital hearing aid terminology made simple : a handy glossary. Hear J 2000;53(3):37,40-44. Agnew J. Hearing Aid Adjustment Through Potentiometers and Switch Options. In: Valente M (ed). Hearing Aids: Standards, Options and Limitations. Thieme Medical, 1996; 210-251. American National Standards Institute. American National Standard for Testing Hearing Aids with a Broad-Band Noise Signal. (ANSI S3.42-). ANSI., 1992 American National Standards Institute. American National Standard for Specification of Hearing Aid Characteristics.(ANSI S3.22-). ANSI, 1996 American National Standards Institute. Specification of Hearing Aid Characteristics (ANSI S3.22-). Acoustical Society of America, 1987 Andersen T, Pedersen F, Parving A, Lyregaard P. Procedure for clinical testing of hearing aids. Scand Audiol 1998;27:249-254. Anonymous News from Oticon Oticon, 1998 Anonymous. Radiofrequency interference with medical devices. A technical information statement. IEEE Engineering in Medicine & Biology Magazine. 1998;17(3):111-4. Appollonio I. Carabellese C. Frattola L. Trabucchi M. Effects of sensory aids on the quality of life and mortality of elderly people: a multivariate analysis. Age & Ageing 1996;25(2):89-96 Arlinger SD. Clinical assessment of modern hearing aids. Scand Audiol Suppl 1998;49:50-3 Bamford J, McCracken W, et al. A pilot field trial of a 2-chanel hearing aid (low frequency compression - high frequency linear amplification) with school age children. University of Manchester, 1998 Barry SJ. Review of hearing aid amplification circuits. J Am Acad Audiol 1998;9:105-111. Berninger E, Nordstrom I. Multiple memory hearing aid. Consistency of program-usage in real-world listening situations. Scand Audiol 1997;26(4):252-6. Brooks DN Time course of adaptation to hearing aid use. Br J Audiol 1996;30:55-62

Brooks DN. Some factors influencing choice of type of hearing aid in the UK: behind-the-ear or in-the-ear. Br J Audiol 1994;28(2):91-8 Bulow Field test of SENSO. Widex Press 1996;June Chabries D, Christiansen R, Brey R, Robinette M, Harris R. Application of adaptive signal processing to speech enhancement for the hearing impaired. J Rehab Res 1987;24(4):65-74. Chouard C, Ouayoun M, Meyer B, Coudert C, Sequeville T, Bachelot G, Genin J. Auditory performances of a 3-4-7 programmable numeric filter hearing aid. Audiology 1997;36:339-353. Chouard CH, Ouayoun M, Meyer B, Coudert C, Sequeville T, Bachelot G, Genin J. Digital multi-filter auditory prosthesis: study of its efficiency in function of number of filters and their programming. Ann Oto-Laryngol Chir Cerv-Fac 1998;115(3):118-28. Chouard CH. Hearing impairment fitting: study of an auditory prosthesis with 7 entirely programmable filters. Bull Acad Nat Med 1997;181(2):275-86. Clasen T, Vesterager V, et al. In-the-ear hearing aids; A comparative investigation of the use of custom-made versus modular type aids. Scand. Audiol 1987;16(4):195-200. Cohen NL, Waltzman SB. Shapiro WH. Clinical trials with a 22-channel cochlear prosthesis. Laryng 1985;95(12):1448-54. Crain TR. Van Tasell DJ. Effect of peak clipping on speech recognition threshold. Ear Hear 1994;15(6):443-53 Csermak B. A primer on a dual microphone directional system. Hear Rev 2000;(1):56,58,60. Dillon H. Compression in Hearing Aids. In: Sandlin R, (ed.) Handbook of Hearing Aid Amplification, Vol 1. Little Brown, 1988; Vol 1:121-146. Dirks DD. Wilson RA. Binaural hearing of speech for aided and unaided conditions. J Sp Hear Res 1969;12(3):650-64 Dye et al Influence of amplification on the psychological functioning of older adults with neurosensory hearing loss J Acad Rehab Aud 1983; 16:210-220 Dyrlund O, Bisgaard N. Acoustic feedback margin improvements in hearing instruments with a prototype DFS (digital feedback suppression system) Scand Audiol 1991;20: 49-53. Dyrlund O. Henningsen LB. Bisgaard N. Jensen JH. Digital feedback suppression (DFS). Characterization of feedback-margin improvements in a DFS hearing instrument Scand Audiol. 1994; 23(2):135-8

Edwards B, Struck C, Dharan P, Hou Z. Signal-processing algorithms for a new software-based, digital hearing device. Hear J 1988;51(8):38-49. Engebretson AM, French-St M, et al. Adaptive feedback stabilization of hearing aids. Scand Audiol Suppl 1993;38: 56-64. Engebretson M, Morley R, Popelka G. Development of an ear-level digital hearing aid and computer-assisted fitting procedure: an interim report. J Rehab Res 1987;24(4):55-64. Engebretson M, Popelka G, Morley R, Niemoeller A, Heidbreder A. A digital hearing aid and computer-based fitting system. Hear Instrum 1986;37(2):8,1112,14. Fabry DA, Leek MR, et al. Do adaptive frequency response (AFR) hearing aids reduce 'upward spread' of masking. J Reh Res Devpt 1993; 30(3):318325. Festen JM, Dukuizen JNV, et al. The efficacy of a multichannel hearing aid in which the gain is controlled by the minima in the temporal signal envelope. Scand. Audio Supp. 1993;38:101-110. Fortune T. Amplifiers and circuit algorithms of contemporary hearing aids. In: Valente M (ed.) Hearing Aids : Standards, Options and Limitations. Thieme Medical, 1996;152-209. Frank T, Gooden RG. The effect of hearing aid microphone types on speech scores in a background of multi-talker noise. Maico Audiol Library Series 1973;11(5):1-4. Frederiksen E, Blegvad B, et al. Binaural hearing aid treatment of presbycusis patients aged 70 to 80 years. Scand. Audiol 1974;3:83-86. French-St. George M, Wood , D, Engebretson M. Behavioral assessment of adaptive equalization in a digital hearing aid. J Rehab Res 1993; 30(1):17-25. Golabek W. Nowakowska M. Siwiec H. Stephens SD. Self-reported benefits of hearing aids by the hearing impaired. Br J Audiol 1988;22(3):183-6 Goldberg H. Psychoacoustic and design considerations in hearing aids. In: Sandlin R, (ed) Handbook of Hearing Aid Amplification, Vol 1. Little Brown, 1988; 31-44. Granstrom G, Tjellstrom A. Guided tissue generation in the temporal bone. Ann Oto Rhin Laryng 1999;108(4):349-54. Hakansson B, Carlsson P, Brandt A, Stenfelt S. Linearity of sound transmission through the human skull in vivo. J Acoust Soc Am 1996;99(4 Pt 1):2239-43

Hall M & Sandlin R Clinical utility of a true DSP instrument Hearing J 1997;50(5):34,37-38 Harless EL. McConnell F. Effects of hearing aid use on self concept in older persons. J Sp Hear Dis. 1982;47(3):305-9 Harris R, Brey R, Chang Y, Soria D, Hilton L. The effects of digital quantization error on speech intelligibility and perceived sound quality. J Speech Hear Res 1991 34:189-196. Hecox K, Punch J. The impact of digital technology on the selection and fitting of hearing aids. Amer J Otol (Suppl 9):1988;77-85. Hellgren J, Lunner T, Arlinger S. System identification of feedback in hearing aids. J Acoust Soc Amer 1999;105:3481-3496. Hemsley R et al. An investigation into the service implications and benefits (On behalf of the Hearing Aids Commodity Advisory Panel) Henrichsen J, Noring E, et al. In-the-ear hearing aids: The use and benefit in the elderly hearing-impaired. Scand Audiol 1988;17(4). Henrichsen J, Noring E, et al. The use and benefit of in-the-ear hearing aids: A four year follow-up examination. Scand Audiol 1991;20(1): 55-59. Hidaka H, Kawase T, Takahashi S, Suzuki Y, Ozawa K, Sakamoto S, Sakai N, Hirano K, Ueda N, Sone T, Takasaka S. Scand Audiol 1998;27:225-236. Hodgson W. Special cases in hearing aid assessment. In: Hodgson W, (ed.) Hearing Aid Assessment ands Use in Audiologic Habilitation. Williams and Wilkins, 1986; 191-216. Hoffman M, Stewart R. Simulation of multi-microphone hearing aids in multiple interference environments. Br J Audiol 1996;30:249-260. Humes LE, Christensen L, et al. A comparison of the aided performance and benefit provided by a linear and a two-channel wide dynamic range compression hearing aid. J Sp Lang Hear Res 1999; 42: 65-79. Jerger J, Carhart R, et al. Binaural hearing aids and speech intelligibility. J Sp Hear Res 1961;4(2): 137-148. Jerlvall L, Almqvist B, et al. Clinical trial of in-the-ear hearing aids. Scand Audiol 1983;12: 63-70. Jordan O, Greison O, et al. Treatment with binaural hearing aids. Arch Otolaryng 1967;85: 319-326.

Keidser G, Dillon H, Byrne D. Guidelines for fitting multiple memory hearing aids. J. Am. Acad. Audiol. 1996,7: 406-418 Kiessling J. Steffens T. Comparison of a programmable 3-channel compression hearing system with single-channel AGC instruments. Scand Audio Suppl. 1993;38:67-74 Killion M. The SIN report: circuits havent solved the hearing-in-noise problem. Hear J 1997;50(10):28-30, 32. Killion M. Hearing aids: past present, future: moving toward normal conversation in noise. Br J Audiol 1997;31:141-148 Killion M. Principles of high fidelity hearing aid amplification. In: Sandlin R. (ed.) Handbook of Hearing Aid Amplification. Little Brown, 1988 Killion M. SNR loss: I can hear what people say, but I cant understand them. Hear Rev 1997;4(12):8,10,12,14. Killion MC. The K-amp hearing aid: an attempt to present the high fidelity for the hearing impaired. Am J Audiol 1993;2(2): 52-74 Kompis M, Dillier N. Noise reduction for hearing aids: combining directional microphones with an adaptive beamformer. J. Acoust. Soc. Am. 1994;96(3):1910-1913 Kuk F, Ludvigsen C. Verifying the output of digital nonlinear hearing instruments. Hear Rev 1999;6(11)35-36,38,60,62,75 Kuk F, Nielsen K. Factors affecting interference from digital cellular phones. Hear J 1997;50(9):1-3. Kuk F. Open or closed? Lets weigh the evidence. Hear J 1997; 50(10):1-2. Kuk F. Rationale and requirements for a slow-acting compression hearing aid. Hear J 1997;51(6):45-53;79. Kuk F. Theoretical and practical considerations in compression hearing aids. Trends Ampl 1996;1(1):1-39. Kuk F. Variables affecting the use of prescriptive formulae to fit modern nonlinear hearing aids. J Amer Acad Audiol 1999;10:458-465. Kuk F. Rational for binaural hearing aid fittings. Widex Press 1999;13. Larseen Dept Audiology, Univ Denmark,1993 Leeuw AR, Dreschler WA. Advantages of directional hearing aid microphones related to room acoustics. Audiology 1991;30: 330-344.

Levitt H, Neuman A, Sullivan J. Studies with digital hearing aids. Acta Otolaryng Suppl 1990;469:57-69. Levitt H. Digital hearing instruments: a brief overview. Hear Instrum 1988;39(4):8,11-12. Levitt H.. A brief history of digital hearing aids. Hear 1988; J 41(4):15,1718,20-21. Levitt H.. Digital hearing aids: a tutorial review. J Rehab Res 1987; 24(4): 720. Ludvigsen C, Topholm J. Fitting a wide dynamic range hearing instrument using real ear threshold data: a new strategy. Hear Rev : High Performance Solutions 1997 2:37-39. Lundh P and Nielsen C. Multifocus field test. (Oticon internal report ; 14-8-12). Oticon Research Unit, 1992. Lunner T, Hellgren J, Arlinger S, Elberling C. A digital filterbank hearing aid: improving a prescriptive fitting with subjective adjustments. Scand Audiol 1997;26:169-176. Lunner T, Arlinger S, Hellgren J. 8-channel digital filter feedbank for hearing aid use: preliminary results in monaural, diotic and dichotic modes. Scand Audiol Suppl 1993;38:75-81. Lurquin P, Rafhay S. Intelligibility in noise using multi-microphone hearing aids. Acta Oto-Rhin-Laryng (Belg) 1996; 50:103-109. Lybarger S. A Historical Overview. In: Sandlin R, ed. Handbook of Hearing Aid Amplification, Little Brown, 1988 (Vol 1) Madison TK, Hawkins DB. The signal-to-noise ratio advantage of directional microphones. Hear Instrum 1983; 34(2):18,49. May A Multi-microphone instruments, DSP and hearing-in-noise. Hear Rev 1998;5(7)42-45. Mccandless & Farmer Internal report. University of Utah, 1999 Miller E. Digital signal processing in hearing aids: implications and applications. Hear J 1988;41(4):22-24,26. Moore BC, Johnson JS, Clark TM, Pluvinage V. Evaluation of a dual-channel full dynamic range compression system for people with sensorineural hearing loss. Ear Hear 1992;13(5): 349-370.

Moore BC. Peters RW. Stone MA. Benefits of linear amplification and multichannel compression for speech comprehension in backgrounds with spectral and temporal dips. J Acoust Soc Am. 1999;105(1):400-11. Moore BCJ, Laurence RF, et al. Improvements in speech intelligibility in quiet and in noise produced by two-channel compression hearing aids. Br J Audiol 1985;19:175-187. Mulrow CD. Aguilar C. Endicott JE. Velez R. Tuley MR. Charlip WS. Hill JA. Association between hearing impairment and the quality of life of elderly individuals. J Am Ger Soc.1990;38(1):45-50 Mulrow CD. Tuley MR. Aguilar C. Correlates of successful hearing aid use in older adults. Ear Hear 1992;13(2):108-13 Murray DJ, Hanson JV, Application of digital signal processing to hearing aids: a critical survey. J Am Acad Audiol 1992;3:145-152. Mylanus EA, Snik FM, Cremers CW, Jorritsma FF, Verschuure H. Audiological results of the bone-anchored hearing aid HC200: multicenter results. Ann Oto Rhin Laryng 1994;103(5 Pt 1):368-74. National Council on the Aging (NCOA). The consequences of untreated hearing loss in older persons. URL: http://www.ncoa.org/news/hearing/untreated_hearing_loss_study.htm [14 April 2000] National Deaf Childrens Society National Standards for Children. Naylor G, Elberling C. The JUMP-1 scheme: An example of industry providing academia with something other than money. ACUSTICA, 1999;85(5):611-614 Naylor G. Technical and audiological factors in the implementation and use of digital signal processing hearing aids. Scand Audiol 1997;26:233-239. Neuman A. Digital technology and clinical practice: the outlook for the future. J Rehab Res 1987;24(4):1-6. Newman CW. Weinstein BE. The Hearing Handicap Inventory for the Elderly as a measure of hearing aid benefit. Ear Hear.1988;9(2):81-5 Nielsen B. Digital hearing aids : where are they? Hear Instr 1986;37(2):6,45. Noble W. Byrne D. A comparison of different binaural hearing aid systems for sound localization in the horizontal and vertical planes Br J Audiol 1990;24(5):335-46. Nowotarski H. . Patents: digital hearing aids and related devices. J Rehab Res 1987; 24(4): 295-304.

Nowotarski H. Literature search on publications on digital hearing aids. J Rehab Res 1987;24(4):293-294. Nunley J, Staab W, Steadman J, Wechsler P, Spencer B. A wearable digital hearing aid. Hear J 1983; 36(10):29-30,3234-35. Nystrand A. Bone-anchored hearing aids and implants in the cochlea improve hearing. Lakartidningen, 1991;88(3):137-8,143-4. Olsen J, Ahlbom C. From acoustic amplification to hearing loss compensation Rev Laryng Oto Rhin. 1993; 14(5):365-371 Olsen SO & Bulow Performance of the SENSO C9 directional Widex Press 1997;July Olsen W. Physical characteristics of hearing aids. In: Hodgson W, (ed.) Hearing Aid Assessment ands Use in Audiologic Habilitation. Williams and Wilkins, 1986;13-37. Olsen, W.O. & Carhart, R. Development of test procedures for evaluation of binaural hearing aids. Bull Prosth Res,1967;10-7 Parent TC, Chmiel R, et al. Comparison of performance with frequency transposition hearing aids and conventional hearing aids. J. Am Acad Audiol 1997, 8: 355-365. Parsons J Effectiveness of NHS hearing aid prescriptions. (MSc dissertation proposal) Parving A. Boisen G. In-the-canal hearing aids. Their use by and benefit for the younger and elderly hearing-impaired. Scand Audiol. 1990;19(1):25-30. Petersen T and Lundh P. Multifocus Power field-test. (Oticon internal report 14-8-13). Oticon Research Unit, 1992. Peterson Hearing Instruments 1993; 44(4);33-35 Plomp R. Noise, amplification, and compression: considerations of three main issues in hearing aid design. Ear Hear 1994;15(1):2-12. Plomp R. The negative effect of amplitude compression in multichannel hearing aids in the light of the modulation-transfer function. J. Acoust Soc Am 1988;83(8):2322-2327. Preves D, Curran J. Hearing aid instrumentation and procedures for electroacoustic testing. In: Valente M, Roeser R, Hosford-Dunn H, eds, Audiology: Treatment Strategies Thieme Medical, 1999 Preves D. Digital hearing aids. Asha 1987;29(9):45-47.

Preves D. Principles of Signal Processing. In: Sandlin R, ed. Handbook of Hearing Aid Amplification, Vol 1. Little Brown, 1988 Preves D. Directions for Future Developments in Hearing Aid Technology. In: Hodgson W, ed. Hearing Aid Assessment ands Use in Audiologic Habilitation. Williams and Wilkins, 1986 Preves D. Future trends in hearing aid technology. In: Valente M ed. Hearing Aids: Standards, Options and Limitations. Thieme Medical,1996 Preves DA, Sammeth CA, et al. Field trial evaluations of a switched directional/omni-directional In-the-ear hearing instrument. J Am Acad Audiol 1999;10:273-284. Reeves D et al. Community provision of hearing aids and related audiology services. (HTA 93/35/02 revised draft report) (in press) Ricketts T, Mueller G. Making sense of directional microphone hearing aids. Amer J Audiol 1999;8(2):117-127. Ricketts T. Directivity quantification in hearing aids: fitting and measurement effects. Ear Hear 2000;21:45-58. Roeser R, Taylor K. Audiometric and field trials with a digital hearing instrument. Hear Instrum 1988; 39(4):14-16,18,20,22. Sammeth CA, Ochs MT. A review of current "noise reduction" hearing aids: rationale assumptions, and efficacy. Ear Hear 1991;12(6): 116s-124s. Schuchman G, Franqui M, Beck LB. Comparison of performance with a conventional and a two-channel hearing aid. J Am Acad Audiol 1996;7:15-22 Schum DJ. Responses of elderly hearing aid users on the hearing aid performance inventory. J Am Acad Audiol 1992;3(5):308-14 Schweitzer C. Development of Digital Hearing Aids. Trends in Amplification 1997;2(2):41-77. Schweitzer CKG. Binaural beamforming and related digital processing for enhancement of signal-to-noise ratio in hearing aids. Current Opinion in Otolaryngology & Head and Neck Surgery 1996;4:335-339. Songbird Internal Company trial: Sept to Oct 1999; Staab W, Lybarger S. Characteristics and Use of Hearing Aids. In: Katz J, ed. Handbook of Clinical Audiology (4th ed.). Williams and Wilkins,1994. Staab W. Digital hearing aids. Hear Instrum 1985; 36(11):14,16,19-20,22,2324. Staab W. Digital hearing instruments. Hear Instrum 1987; 38(11):18,21-22,26.

Staab W. Digital/programmable hearing aids- an eye towards the future. Br J Audiol 1990;24:243-256. Studebaker GA, Sherbecoe RL, Matesich JS. Spectrum shaping with a hardware digital filter. J Reh Res Devpt 1987;24(4):21-8. Surr RK, Cord MT, Walden BE. Long-term versus short-term hearing aid benefit J Am Acad Audiol 1998;9(3):165-71. Taubman LB, Palmer CV, Durrant JD, Pratt S. Accuracy of hearing aid use time as reported by experienced hearing aid wearers. Ear Hear 1999;20(4):299-305 Tesch-Romer C. Psychological effects of hearing aid use in older adults. J of Gerontol. Series B, Psychological Sciences & Social Sciences.1997; 52(3):P127-38 Tjellstrom A, Hakansson B. The bone-anchored hearing aid. Design principles, indications, and long-term clinical results. Otolaryng Clin N Am, 1995;28(1):53-72. Turner CW. Humes LE. Bentler RA. Cox RM. A review of past research on changes in hearing aid benefit over time. Ear Hear 17(3)Suppl:14S-25S Upfold LLP. Directional advantage with lower gain directional hearing aids. Aust J Audiol 1996;18(1):35-45. Valente M Fabry D, Potts L, Sandlin R. Comparing the performance of the Widex Senso digital hearing aids with analog hearing aids. J Amer Acad Audiol 1998;9:342-360. Valente M, Fabry DA, et al. Recognition of speech noise with hearing aids using dual-microphones Phonak Focus 1995;19. Valente M, Sweetow R, Potts L, Bingea B. Digital versus analog signal processing: effect of directional microphone. J Amer Acad Audiol 1999;0:133150. van der Pouw KT, Snik AF, Cremers CW. Audiometric results of bilateral bone-anchored hearing aid application in patients with bilateral congenital aural atresia. Laryngoscope 1998;108(4 Pt 1):548-53. Verschuure J, Benning FJ, et al. Speech intelligibility in noise with fast compression hearing aids. Audiology 1998,37:127-150. vonFeldt JR. A description of the DAVID interactive instructional television system and its application to post-high school education of the deaf. Journal of Medical Systems, 1979;3(1-2):55-68.

Walden BE, Surr RK, Cord MT, Pavlovic CV. A clinical trial of the ReSound IC4 hearing device. Am J Audiol 1999;8(1):65-78. Waldhauer F, Villchur E. Full dynamic range multiband compression in a hearing aid. Hear J: 1988;29-32. Wazen JJ, Wright R, Hatfield RB, Asher ES. Auricular rehabilitation with boneanchored titanium implants. Laryngoscope 1999;109(4):523-7. Weinstein BE. Age-related hearing loss: how to screen for it, and when to intervene. Geriatrics, 1994; Aug, 49(8):40-5; quiz 46-7. Weinstein BE. Treatment Efficacy: Hearing Aids in the Management of Hearing Loss in Adults. J Sp Hear Res 1996;39:S37-S45. Winter & Kuk Hear Rev 1998 Wesselkamp M. Results of a clinical study of PRISMA BTE at the University of Giessen. (Version 1.0, 5-Feb-99). Siemens, 1999

Experts consulted during review: Professor Adrian Davis, MRC Institute for Hearing Research, Nottingham; Professor Stuart Gatehouse, MRC Institute for Hearing Research; Glasgow, Professor Mark Lutman, Dept???? University of Southampton; Mr Jonathan Parsons, Department of Audiology, Royal Devon & Exeter Healthcare Trust. Report submitted to peer-review by: Professor Adrian Davis, Professor Mark Lutman, Mr Jonathan Parsons.