A multi-center,double blind clinical trial comparing benefit from three commonly used hearing aid circuits

OBJECTIVE: Although numerous studies have demonstrated that hearing aids provide significant benefit, carefully controlled, multi-center clinical trials have not been conducted. A multi-center clinical trial was conducted to compare the efficacy of three commonly used hearing aid circuits: peak clipping, compression limiting, and wide dynamic range compression. DESIGN: Patients (N = 360) with bilateral, sensorineural hearing loss were studied using a double blind, three-period, three-treatment crossover design. The patients were fit with each of three programmable hearing aid circuits. Outcome tests were administered in the unaided condition at baseline and then after 3 mo usage of each circuit, the tests were administered in both aided and unaided conditions. The outcome test battery included tests of speech recognition, sound quality and subjective scales of hearing aid benefit, including patients' overall rank-order rating of the three circuits. RESULTS: Each hearing aid circuit improved speech recognition markedly, with greater improvement observed for soft and conversationally loud speech in both quiet and noisy listening conditions. In addition, a significant reduction in the problems encountered in communication was observed. Some tests suggested that the two compression hearing aids provided a better listening experience than the peak clipping hearing aid. In the rank-order ratings, patients preferred the compression limiting hearing aid more frequently than the other two hearing aids. CONCLUSIONS: The three hearing aid circuits studied provide significant benefit both in quiet and in noisy listening situations. The two compression hearing aids appear to provide superior benefits compared to the linear circuit, although the differences between the hearing aids were smaller than the differences between unaided and aided conditions.     

A comparison of two-channel and single-channel compression hearing aids

Eight subjects with bilateral sensorineural hearing losses took part in a trial comparing listening unaided with listening binaurally through two types of hearing aid, aid A and aid B. Both aids incorporated slow-acting automatic gain control (AGC) operating on the whole speech signal. However, aid A also incorporated two-channel syllabic compression. The two aids were chosen to be as similar as possible in other respects, and both were worn behind the ear. Subjects were tested in a counter-balanced order, and had at least 2 weeks of everyday experience with each aid before testing took place. Performance was evaluated in three ways: by measuring speech intelligibility in quiet for sentences at three peak sound levels, 55, 70 and 85 dB SPL; by measuring the level of speech required for 50% intelligibility (called the SRT) of sentences in two levels of speech-shaped noise, 60 and 75 dB SPL; and by administering questionnaires about experience with the aids in everyday life. Both aid A and aid B improved the intelligibility of speech in quiet relative to unaided listening, particularly at the lowest sound level. However, aid A gave lower (i.e., superior) SRTs in speech-shaped noise than aid B or unaided listening. The questionnaires also indicated that aid A gave better performance in noisy situations. The results strongly suggest that two-channel syllabic compression, combined with slow-acting AGC operating on the whole speech signal, can give superior results to slow-acting AGC alone, particularly in noisy situations.     

Patient experiences with multiband full dynamic range compression.

This investigation compared performance for 18 experienced hearing aid patients with a multiband full dynamic range compression hearing device and their previously worn linear or automatic gain control hearing aids. Performance was evaluated using a variety of clinical tests. These included functional gain and dynamic range measurements, speech recognition, and real ear measurements. Patients rated their performance with the multiband compression device and their previously worn aids on a rating scale pertaining to a variety of real life listening situations. Statistical analysis of data derived from test results shows significantly improved performance on all measures using the multiband compression aid over their conventional aids. Patients rated their performance higher with the compression instrument than with the conventional aids. Differences in performance on clinical tests and subjective patient responses appear to be related to the different signal processing schemes used in the two groups of devices.     

Early clinical results: SOUNDTEC implantable hearing device phase II study

OBJECTIVE: To assess the safety and efficacy of a new semi-implantable electromagnetic hearing device, the SOUNDTEC Direct Drive Hearing System (DDHS), and to compare its performance with that of subjects' previously worn, optimally fit hearing aids. Preliminary results for the first 10 subjects are presented. STUDY DESIGN: The protocol specified in the Investigational Device Exemption is used in this ongoing FDA phase II 100-subject multicenter clinical trial. METHODS: For baseline, each subject is tested wearing his or her own optimally fit hearing aid in the ear to be implanted. Six-month postoperative outcome measures using the SOUNDTEC DDHS are compared with the baseline. Multiple objective and subjective outcomes (as listed under Results) were measured. RESULTS: When compared with the subjects' optimally fit hearing aids, the SOUNDTEC DDHS provided an average improvement of 52% in functional gain (250-6000 Hz), 22% in aided thresholds, 3.8% for speech discrimination in quiet, 17% for speech in noise, 13.1% in articulation index scores, 28% in aided benefit, 27.3% in sound quality of speech, and a 16.7% increase in overall subject satisfaction. In addition, with the SOUNDTEC DDHS, subjects reported absence of acoustic feedback, little or no occlusive effects, and more natural sound perception. CONCLUSION: Analysis of data on the first 10 subjects using the SOUNDTEC DDHS indicates positive outcomes regarding safety and efficacy, although the small sample size is not sufficient to permit valid statistical inferences to be drawn from our preliminary data. Results also demonstrate improvement in performance compared with the subjects' optimally fit hearing aids and an improvement in quality of life as demonstrated by objective and subjective tests and measures.     

Predictability of speech-in-noise performance from real ear measures of directional hearing AIDS

OBJECTIVE: Inability to understand speech in noise has been cited repeatedly as the principal complaint of hearing aid users. While data exist documenting the benefit provided by hearing aids with directional microphones when listening to speech in noise, little work has been done to develop a standard clinical protocol for fitting these hearing aids. Our goal was to evaluate a clinical measure of the acoustic directivity of a directional hearing aid, including its association with a test of speech perception in noise. DESIGN: The performance of two commercially available directional behind-the-ear (BTE) hearing aids was evaluated using the Hearing in Noise Test (HINT) and the Real Ear Aided Response (REAR) on 24 adult participants with symmetric, mild to moderately severe, sensorineural hearing loss. The HINT was conducted with the speech signal presented from 0 degrees and the noise from 180 degrees and either 135 degrees or 225 degrees, depending on the ear tested. REAR was measured at the above three angles using swept pure tones, and these measures were used to compute in situ directivity for each subject and hearing aid. CONCLUSIONS: Directional benefit for the HINT was greatest when noise was presented from the azimuth of the published polar diagram null of a given hearing aid in its directional mode (180 or 135/225 degrees). The only significant correlation between HINT and REAR results, however, was found when the noise source was at 180 degrees. These results confirm the validity of using real ear measures as a way to assess directionality in situ, but also indicate the complexity of predicting perceptual benefit from them. These data suggest that factors beyond acoustic directionality may contribute to improvement in speech perception in noise when such improvements are found.     

Modeling and predicting hearing aid outcome

Following a brief tutorial on the application of factor analysis to hearing aid outcome measures, three studies of hearing aid outcome measures in elderly adults are presented and analyzed. Two of the studies were completed at Indiana University (IU-1 and IU-2), and one was a collaborative multisite study by the Veterans Administration and the National Institute of Deafness and other Communication Disorders (NIDCD/VA). IU-1 measured hearing aid outcome in 173 elderly wearers of single-channel, linear, in-the-ear hearing aids with output-limiting compression, whereas IU-2 obtained the same extensive set of outcome measures from 53 elderly wearers of two-channel, wide-dynamic-range compression, in-the-canal hearing aids. In the NIDCD/VA study, 333 to 338 participants wore three single-channel circuits in succession, with each circuit housed within an in-the-ear shell. The three circuits included in that study and in this analysis were: (1) linear with peak clipping, (2) linear with output-limiting compression, and (3) single-channel, wide-dynamic-range compression. Evaluation of the many outcome measures completed in each study using principal components factor analysis revealed that from three (both IU studies) to five (NIDCD/VA study) principal components captured the individual differences in hearing aid outcome. This was independent of hearing aid type (in-the-ear or in-the-canal) and circuitry. Subsequent multiple regression analyses of individual differences in performance along each dimension of hearing aid outcome revealed that these individual differences could be accounted for reasonably well by various prefit variables for some dimensions of outcome, but not others. In general, measures of speech recognition performance were well accounted for by prefit measures, with the best predictors being hearing loss, cognitive performance, and age. Measures of hearing aid usage were less well accounted for by prefit measures, with the most accurate predictor of current hearing aid use being prior hearing aid use. The outcome dimension accounted for most poorly was that associated with hearing aid satisfaction, with subjective measures of aided sound quality being the best predictor of performance along this dimension of hearing aid outcome. Additional multicenter, large-scale studies are needed to develop more complete models of hearing aid outcome and to identify the variables that influence various aspects of hearing aid outcome. It is only through this additional research that it will be possible to optimize outcome for hearing aid wearers.     

Impact of compression and hearing aid style on directional hearing aid benefit and performance.

OBJECTIVE: To evaluate the impact of low-threshold compression and hearing aid style (in-the-ear [ITE] versus behind-the-ear [BTE]) on the directional benefit and performance of commercially available directional hearing aids. DESIGN: Forty-seven adult listeners with mild-to-moderate sensorineural hearing loss were fit bilaterally with one BTE and four different ITE hearing aids. Speech recognition performance was measured through the Connected Speech Test (CST) and Hearing in Noise Test (HINT) for a simulated noisy restaurant environment. RESULTS: For both the HINT and CST, speech recognition performance was significantly greater for subjects fit with directional in comparison with omnidirectional microphone hearing aids. Performance was significantly poorer for the BTE instrument in comparison with the ITE hearing aids when using omnidirectional microphones. No differences were found for directional benefit between compression and linear fitting schemes. CONCLUSIONS: No systematic relationship was found between the relative directional benefit and hearing aid style; however, the speech recognition performance of the subjects was somewhat predictable based on Directivity Index measures of the individual hearing aid models. The fact that compression did not interact significantly with microphone type agrees well with previously reported electroacoustic data.     

Noise reduction hearing aids: release from masking and release from distortion.

Automatic frequency response (AFR) hearing aids usually reduce their low-frequency gain in the presence of noise; several investigators have reported improved recognition of high-frequency speech information in low-frequency band-limited noise with AFR versus non-AFR hearing aids. In this work, masking patterns (masked threshold for frequency-modulated probe tones as a function of probe frequency) were obtained for a narrowband low-frequency noise. Speech recognition threshold for a set of high-frequency loaded monosyllables also was obtained in the presence of the same noise. Aided speech and masking pattern data for one normal and two hearing-impaired subjects wearing a master hearing aid incorporating a commercially available AFR circuit showed modest AFR effects. Moreover, masking noise spectra measured in ear canals of subjects wearing the master hearing aid showed evidence of substantial hearing aid-generated distortion products in the AFR-off condition. Results obtained from the normal subject listening with a low-distortion laboratory simulation of an AFR hearing aid showed greater release from masking for the same low-frequency attenuation as provided by the hearing aid. Improvements of speech recognition in noise observed with AFR hearing aids may result from some combination of release from upward spread of masking and reduction of distortion products generated by the hearing aid in the non-AFR setting.     

Quantification of directional benefit across different polar response patterns

The purpose of this study was to assess the relationship between the directivity of a directional microphone hearing aid and listener performance. Hearing aids were fit bilaterally to 19 subjects with sensorineural hearing loss, and five microphone conditions were assessed: omnidirectional, cardioid, hypercardioid, supercardioid, and "monofit," wherein the left hearing aid was set to omnidirectional and the right hearing aid to hypercardioid. Speech perception performance was assessed using the Hearing in Noise Test (HINT) and the Connected Speech Test (CST). Subjects also assessed eight domains of sound quality for three stimuli (speech in quiet, speech in noise, and music). A diffuse soundfield system composed of eight loudspeakers forming the corners of a cube was used to output the background noise for the speech perception tasks and the three stimuli used for sound quality judgments. Results indicated that there were no significant differences in the HINT or CST performance, or sound quality judgments, across the four directional microphone conditions when tested in a diffuse field. Of particular interest was the monofit condition: Performance on speech perception tests was the same whether one or two directional microphones were used.     

言语、空间与听觉质量量表在老年听力损失者助听器验配中的应用

目的探讨言语、空间与听觉质量量表(speech,spatial and qualities of hearing scale,SSQ)用于老年听力损失患者佩戴助听器的效果评估作用。方法以100例老年感音神经性听力损失者(60~90岁)为研究对象,采用横断面研究和前瞻性研究,其中,无助听器使用经验者44例(75.8±8.1岁,气导纯音平均听阈59.8±13.3 dB HL)、有助听器使用经验者34例(77.5±6.3岁,气导纯音平均听阈64.5±17.8 dB HL,助听器佩戴时间大于三个月)进行横断面研究;22例(74.3±8.6岁,气导纯音平均听阈58.1±12.6 dB HL)首次配戴助听器者进行前瞻性研究;二组参与横断面研究者进行一次SSQ评估,前瞻性研究组分别在助听前和佩戴助听器1个月后进行二次SSQ评估,均采用面对面问答方式用SSQ量表评估三组受试者在言语理解能力、空间定位能力和声音聆听质量方面的变化。结果横断面研究结果显示,有助听经验组SSQ问卷言语理解(97.29±23.43分)、空间听觉(131.94±19.27分)、声音质量(143.53±20.31分)和总分(372.76±51.92分)均显著高于无助听经验组(分别为58.66±30.13、99.41±37.09、108.09±43.28、266.16±78.18分)。前瞻性研究结果显示,受试者初次佩戴助听器一个月后的SSQ问卷言语理解(106.27±13.86分)、空间听觉(136.00±14.09分)、声音质量(151.73±13.91分)和总分(394.00±34.70分)均显著高于佩戴助听器前(分别为65.64±21.89、115.09±17.17、111.91±25.41、292.64±45.58分),横断面研究和前瞻性研究结果均显示,老年听力损失患者佩戴助听器后在言语理解能力、空间声源定位能力和声音聆听质量方面均有显著改善(P<0.05)。结论SSQ量表可以有效评估老年听力损失患者助听器使用效果;老年听力损失患者佩戴助听器后在言语理解能力、空间定位能力和声音聆听质量方面均有显著提高。     

Hearing aid saturation and aided loudness discomfort.

Clinical measurements of the loudness discomfort level (LDL) are generally performed while the subject listens to a particular stimulus presented from an audiometer through headphones (AUD-HP). The assumption in clinical practice has been that the sound pressure level (SPL) corresponding to the sensation of loudness discomfort under AUD-HP conditions will be the same as the corresponding to LDL with the hearing aid. This assumption ignores the fact that the distortion produced by a saturating hearing aid could have an influence on the sensation of loudness. To examine these issues, 5 hearing-impaired subjects were each fit with four linear hearing aids, each having a different saturation sound pressure level (SSPL90). Probe-tube microphone measurements of ear canal SPL at LDL were made while the subjects listened to continuous discourse in quiet under aided and AUD-HP conditions. Also using continuous discourse, real-ear coherence measures were made at various output sound pressure levels near LDL. All four hearing aid types produced mean LDLs that were lower than those obtained under AUD-HP conditions. Those hearing aids with higher SSPL90 produced significantly higher LDLs than hearing aids with lower SSPL90. A significant negative correlation was found between real-ear SPL and real-ear coherence. Quality judgments made at LDL indicated that sound quality of hearing aids with higher SSPL90 was preferred to that of hearing aids with lower SSPL90. Possible fitting implications regarding the setting of SSPL90 from AUD-HP LDL measures are discussed.     

Comparison of speech perception in background noise with acceptance of background noise in aided and unaided conditions.

Background noise is a significant factor influencing hearing-aid satisfaction and is a major reason for rejection of hearing aids. Attempts have been made by previous researchers to relate the use of hearing aids to speech perception in noise (SPIN), with an expectation of improved speech perception followed by an increased acceptance of hearing aids. Unfortunately, SPIN was not related to hearing-aid use or satisfaction. A new measure of listener reaction to background noise has been proposed. The acceptable noise level (ANL), expressed in decibels, is defined as a difference between the most comfortable listening level for speech and the highest background noise level that is acceptable when listening to and following a story. The ANL measure assumes that speech understanding in noise may not be as important as is the willingness to listen in the presence of noise. It has been established that people who accept background noise have smaller ANLs and tend to be "good" users of hearing aids. Conversely, people who cannot accept background noise have larger ANLs and may only use hearing aids occasionally or reject them altogether. Because this is a new measure, it was important to determine the reliability of the ANL over time with and without hearing aids, to determine the effect of acclimatization to hearing aids, and to compare the ANL to well-established measures such as speech perception scores collected with the SPIN test. Results from 50 listeners indicate that for both good and occasional hearing aid users, the ANL is comparable in reliability to the SPIN test and that both measures do not change with acclimatization. The ANLs and SPIN scores are unrelated. Although the SPIN scores improve with amplification, the ANLs are unaffected by amplification, suggesting that the ANL is inherent to an individual and can be established prior to hearing aid fitting as a possible predictor of hearing-aid use.     

New perspectives on assessing amplification effects

Clinicians have long been aware of the range of performance variability with hearing aids. Despite improvements in technology, there remain many instances of well-selected and appropriately fitted hearing aids whereby the user reports minimal improvement in speech understanding. This review presents a multistage framework for understanding how a hearing aid affects performance. Six stages are considered: (1) acoustic content of the signal, (2) modification of the signal by the hearing aid, (3) interaction between sound at the output of the hearing aid and the listener's ear, (4) integrity of the auditory system, (5) coding of available acoustic cues by the listener's auditory system, and (6) correct identification of the speech sound. Within this framework, this review describes methodology and research on 2 new assessment techniques: acoustic analysis of speech measured at the output of the hearing aid and auditory evoked potentials recorded while the listener wears hearing aids. Acoustic analysis topics include the relationship between conventional probe microphone tests and probe microphone measurements using speech, appropriate procedures for such tests, and assessment of signal-processing effects on speech acoustics and recognition. Auditory evoked potential topics include an overview of physiologic measures of speech processing and the effect of hearing loss and hearing aids on cortical auditory evoked potential measurements in response to speech. Finally, the clinical utility of these procedures is discussed.     

Speech perception for adults who use hearing aids in conjunction with cochlear implants in opposite ears.

This study aimed to (a) investigate the effect of using a hearing aid in conjunction with a cochlear implant in opposite ears on speech perception in quiet and in noise, (b) identify the speech information obtained from a hearing aid that is additive to the information obtained from a cochlear implant, and (c) explore the relationship between aided thresholds in the nonimplanted ear and speech perception benefit from wearing a hearing aid in conjunction with a cochlear implant in opposite ears.Fourteen adults who used the Nucleus 24 cochlear implant system in 1 ear participated in the study. All participants had either used a hearing aid in the nonimplanted ear for at least 75% of waking hours after cochlear implantation, and/or, hearing loss less than 90 dB HL in the low frequencies in the nonimplanted ear. Speech perception was evaluated in 3 conditions: cochlear implant alone (CI), hearing aid alone (HA), and cochlear implant in conjunction with hearing aid in opposite ears (CIHA). Three speech perception tests were used: consonant-vowel nucleus-consonant (CNC) words in quiet, City University of New York style (CUNY) sentences in coincident signal and noise, and spondees in coincidental and spatially separated signal and noise. Information transmission analyses were performed on the CNC responses.Of the 14 participants tested, 6 showed significant bimodal benefit on open-set speech perception measures and 5 showed benefit on close-set spondees. However, 2 participants showed poorer speech perception with CIHA than CI in at least 1 of the speech perception tests. Results of information transmission analyses showed that bimodal benefit (performance with CIHA minus that with CI) in quiet arises from improved perception of the low frequency components in speech. Results showed that participants with poorer aided thresholds in the mid-to-high frequencies demonstrated greater bimodal benefit. It is possible that the mid-to-high frequency information provided by the hearing aids may be conflicting with the cochlear implants.     

Multiple-channel non-linear power hearing instruments for children with severe hearing impairment: long-term follow-up

The long-term benefits of multiple-channel non-linear technology for children with severe hearing impairment have yet to be fully investigated over the longer term. Twenty-one children with severe hearing loss participated in a study comparing performance on measures of audibility, speech understanding (in quiet and noise) and listening situations between the children's current analog hearing aids and a test hearing aid with multiple-channel non-linear compression (DigiFocus II Compact Power). Results were obtained from the children at 2 weeks, 8 weeks, 6 months and 12 months following the fitting of a multiple-channel non-linear hearing instrument. Compared with the children's own hearing instruments, the test instruments provided improved audibility, improvement in speech understanding in quiet and noise, and an improvement in listening skills The gains in speech understanding were greater in noise than in quiet, suggesting that the test hearing instrument provided greatest improvement when listening to speech in noise. While performance increased over time, there was no statistically significant evidence to support continued acclimatization.     

Binaurality in middle ear implant recipients using contralateral digital hearing AIDS.

OBJECTIVE: For some patients, conventional hearing aids might have disadvantages that clearly limit the benefit of using them. The middle ear implant, Vibrant Soundbridge hearing prosthesis offers an approach to help such patients. Our study's objective was to identify the binaurality in a well-fitted digital hearing aid worn in the contralateral ear in recipients experienced with use of the Vibrant Soundbridge middle ear implant device. STUDY DESIGN: In a prospective study, warble-tone thresholds and stereophony were evaluated for the following conditions: (1) binaural unaided-with the middle ear implant inactive and the behind-the-ear hearing aid removed; (2) middle ear implant alone-middle ear implant active, behind-the-ear hearing aid removed; (3) middle ear implant plus behind-the-ear omnidirectional-middle ear implant active, behind-the-ear active; and (4) behind-the-ear omnidirectional alone-middle ear implant inactive, behind-the-ear omnidirectional active. Behind-the-ear omnidirectional and behind-the-ear is defined as the behind-the-ear active in the omnidirectional or directional response, respectively. Behind-the-ear is a contralateral digital hearing aid to the middle ear implant. Benefits such as improved sound detection, speech perception in quiet and in noise, and sound quality were investigated. The evaluation of subjective hearing benefit was based on the Abbreviated Profile of Hearing Aid Benefit (APHAB) test. Paired t tests (subject) were used to analyze the differences between mean thresholds for the different test conditions. SETTING: Tertiary referral center. PATIENTS: Eight adults (aged 45-68 yr) had undergone implantation with a single Vibrant Soundbridge at least 12 months before starting the study. These eight subjects presented no contraindication for contralateral hearing aid use. Patients were fitted 5 weeks before testing with a Siemens Signia digital behind-the-ear hearing aid in the side contralateral to the Vibrant Soundbridge. RESULTS: Five weeks after use of the contralateral hearing aid together with the middle ear implant, mean differences in warble-tone thresholds between Conditions 2 and 3 and between Conditions 3 and 4 were both statistically significant. The mean differences in speech reception thresholds were in line with the mean differences in average warble-tone thresholds. The mean speech reception threshold for the middle ear implant plus behind-the-ear omnidirectional condition was slightly worse (3 dB) than that for the middle ear implant alone condition; however, this difference was not statistically significant. Whereas speech reception threshold difference between Condition 1 and Condition 4 was not statistically significant (60 dB and 61 dB, respectively). The mean difference for the 0-degree azimuth alone was statistically significant (p < 0.05) for the conditions middle ear implant alone and middle ear implant plus behind-the-ear omnidirectional. The middle ear implant alone appears to give good sensitivity at 2 kHz for any direction. Increasing scores indicate greater percentages of problems. Percentages of problems were on average lower for the middle ear implant when used with the contralateral digital hearing aid based on the global score. CONCLUSION: The use of a middle ear implant Vibrant Soundbridge together with a contralateral digital hearing aid improved functional gain and speech perception thresholds in quiet, especially for the sound coming from the front of the patient. The use of a middle ear implant together with a contralateral digital hearing did not significantly improve hearing in noise.     

Multiple-channel non-linear power hearing instruments for children with severe hearing impairment: long-term follow-up

The long-term benefits of multiple-channel non-linear technology for children with severe hearing impairment have yet to be fully investigated over the longer term. Twenty-one children with severe hearing loss participated in a study comparing performance on measures of audibility, speech understanding (in quiet and noise) and listening situations between the children's current analog hearing aids and a test hearing aid with multiple-channel non-linear compression (DigiFocus II Compact Power). Results were obtained from the children at 2 weeks, 8 weeks, 6 months and 12 months following the fitting of a multiple-channel non-linear hearing instrument. Compared with the children's own hearing instruments, the test instruments provided improved audibility, improvement in speech understanding in quiet and noise, and an improvement in listening skills. The gains in speech understanding were greater in noise than in quiet, suggesting that the test hearing instrument provided greatest improvement when listening to speech in noise. While performance increased over time, there was no statistically significant evidence to support continued acclimatization.