Clinical evaluation of an over-the-counter hearing aid (TEO First®) in elderly patients suffering of mild to moderate hearing loss.
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SUBMITTER: Sacco G
PROVIDER: S-EPMC4938978 | biostudies-literature | 2016 Jul
REPOSITORIES: biostudies-literature
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Clinical evaluation of an over-the-counter hearing aid (TEO First®) in elderly patients suffering of mild to moderate hearing loss.
Sacco Guillaume G Gonfrier Sébastien S Teboul Bernard B Gahide Ivan I Prate Fredéric F Demory-Zory Mathilde M Turpin Jean-Michel JM Vuagnoux Claire C Genovese Philippe P Schneider Stéphane S Guérin Olivier O Guevara Nicolas N
BMC geriatrics 20160709
<h4>Background</h4>Presbycusis has a direct influence on autonomy of the elderly but hearing aids lack of affordability. Moreover a recent review demonstrate that electroacoustic characteristics of OTC hearing aids were generally not suitable for the elderly people. In our study, we assessed the clinical value of a new over-the-counter (OTC) hearing aid device (TEO First®) in the elderly.<h4>Method</h4>This prospective monocentric open label study included patients over 60 years of age with a mi ...[more]
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Project description:ImportanceHearing loss is a highly prevalent condition, with numerous debilitating consequences when left untreated. However, less than 20% of US adults with hearing loss use hearing aids. Over-the-counter (OTC) hearing aids became available in October 2022 to improve access and affordability. However, clinical effectiveness studies of available OTC hearing aids using the existing devices in the market are limited.ObjectiveTo compare the clinical effectiveness of a self-fitting OTC hearing aid with remote support and a hearing aid fitted using audiologist-fitted best practices.Design, setting, and participantsThis randomized clinical effectiveness trial was conducted between April 14 and August 29, 2022. Sixty-eight adults with self-perceived mild to moderate hearing loss were recruited and randomly assigned to either the self-fitting or the audiologist-fitted group. Following bilateral hearing aid fitting, participants first completed a 2-week, take-home field trial without any support. Access to fine-tuning for both groups was only available after the 2-week trial. Support and adjustment were provided remotely for the self-fitting group per request and by the audiologist for the audiologist-fitted group. Participants were then reassessed after an additional 4-week take-home trial.InterventionsA commercially available self-fitting OTC hearing aid was provided to participants in the self-fitting group who were expected to set up the hearing aids using the commercially supplied instructional material and accompanying smartphone application. In the audiologist-fitted group, audiologists fitted the same hearing aid according to the National Acoustics Laboratories nonlinear version 2 algorithm for prescriptive gain target using real-ear verification with hearing aid use instruction.Main outcomes and measuresThe primary outcome measure was self-reported hearing aid benefit, measured using the Abbreviated Profile of Hearing Aid Benefit (APHAB). Secondary measures included the International Outcome Inventory for Hearing Aids (IOI-HA) and speech recognition in noise measured using an abbreviated speech-in-noise test and a digits-in-noise test. All measures were completed at baseline and at 2 intervals following hearing aid fitting (2 and 6 weeks).ResultsSixty-four participants were included in the analytic sample (33 men [51.6%]; mean [SD] age, 63.6 [14.1] years), with equal numbers of participants (n = 32) randomized into each group. The groups did not differ significantly in age (effect size r = -0.2 [95% CI, -0.3 to 0.2]) or 4-frequency pure-tone average (effect size r = 0.2 [95% CI, -0.1 to 0.4]). After the 2-week field trial, the self-fitting group had an initial advantage compared with the audiologist-fitted group on the self-reported APHAB (Cohen d = -0.5 [95% CI, -1.0 to 0]) and IOI-HA (effect size r = 0.3 [95% CI, 0.0-0.5]) but not speech recognition in noise. At the end of the 6-week trial, no meaningful differences were evident between the groups on any outcome measures.Conclusion and relevanceIn this randomized clinical effectiveness trial, self-fitting OTC hearing aids with remote support yielded outcomes at 6 weeks post fitting comparable to those of hearing aids fitted using audiologist best practices. These findings suggest that self-fitting OTC hearing aids may provide an effective intervention for mild to moderate hearing loss.Trial registrationClinicalTrials.gov Identifier: NCT05337748.
| S-EPMC10102918 | biostudies-literature
Project description:BackgroundHearing loss is a growing health concern worldwide. Hearing aids (HAs) are the treatment of choice for hearing rehabilitation in most cases of mild-to-moderate hearing loss. However, many patients with hearing loss do not use HAs due to their high cost, stigma, and inaccessibility. Since smartphones are widely used, many apps that mimic the amplification function of HAs have been introduced. Smartphone-based HA apps (SHAAs) are affordable and easy to access. However, the audiological benefit of SHAAs has not been determined.ObjectiveWe compared the audiological performance between an SHAA and a conventional HA in a prospective, multicenter randomized controlled trial.MethodsPatients with mild-to-moderate hearing loss were prospectively enrolled from 2 tertiary hospitals and randomly assigned to either an SHAA (Petralex; IT4YOU Corp LLC) or a conventional HA (Siya 1 miniRITE; Oticon A/S). For the cross-over study design, participants used the alternate device and repeated the same 2-month trial. Audiological measurements were obtained using hearing tests, real-ear measurements, and the hearing-in-noise test (HINT). Subjective satisfaction was evaluated using the Abbreviated Profile of Hearing Aid Benefit (APHAB) and International Outcome Inventory for Hearing Aids (IOI-HA).ResultsOverall, 63 participants were screened and 38 completed the study. In sound-field audiometry testing, the SHAA showed a 20- to 60-dB gain in the low-to-high frequencies of the hearing threshold level. The HA provided adequate gain in the middle-to-high frequencies (55, 65, and 75 dB in real-ear measurements), which is the sound level for most speaking volumes. However, the SHAA could not improve word recognition at 50 dB. The HA showed better audiological performance than the SHAA in both quiet and noisy conditions in the HINT. The IOI-HA scores were significantly improved by both the HA and SHAA versus unaided conditions. Among the SHAA users, 37% (14/38), 42% (16/38), 24% (9/38), and 32% (12/38) showed improvement in APHAB scores for ease of communication, reverberation, background noise, and aversiveness of sounds, respectively. There were no differences in adverse events between the 2 study groups.ConclusionsThe HA showed better performance than the SHAA in word recognition and the HINT. However, the SHAA was significantly better than unaided hearing in terms of amplification. The SHAA may be a useful hearing assistance device for patients with mild-to-moderate hearing loss when listening to soft sounds in quiet conditions. The SHAA demonstrated poorer performance than the HA in the mid- to high-frequency sounds that are important for word recognition, sound quality, and hearing in noisy conditions. Further development of the signal technology of SHAAs is needed to improve the sound quality of mid- to high-frequency sounds and overcome noisy environments.
| S-EPMC10578122 | biostudies-literature
Project description:ObjectivesThe purpose of the present study was to investigate the laboratory efficacy and real-world effectiveness of advanced directional microphones (DM) and digital noise reduction (NR) algorithms (i.e., premium DM/NR features) relative to basic-level DM/NR features of contemporary hearing aids (HAs). The study also examined the effect of premium HAs relative to basic HAs and the effect of DM/NR features relative to no features.DesignFifty-four older adults with mild-to-moderate hearing loss completed a single-blinded crossover trial. Two HA models, one a less-expensive, basic-level device (basic HA) and the other a more-expensive, advanced-level device (premium HA), were used. The DM/NR features of the basic HAs (i.e., basic features) were adaptive DMs and gain-reduction NR with fewer channels. In contrast, the DM/NR features of the premium HAs (i.e., premium features) included adaptive DMs and gain-reduction NR with more channels, bilateral beamformers, speech-seeking DMs, pinna-simulation directivity, reverberation reduction, impulse NR, wind NR, and spatial NR. The trial consisted of four conditions, which were factorial combinations of HA model (premium versus basic) and DM/NR feature status (on versus off). To blind participants regarding the HA technology, no technology details were disclosed and minimal training on how to use the features was provided. In each condition, participants wore bilateral HAs for 5 weeks. Outcomes regarding speech understanding, listening effort, sound quality, localization, and HA satisfaction were measured using laboratory tests, retrospective self-reports (i.e., standardized questionnaires), and in-situ self-reports (i.e., self-reports completed in the real world in real time). A smartphone-based ecological momentary assessment system was used to collect in-situ self-reports.ResultsLaboratory efficacy data generally supported the benefit of premium DM/NR features relative to basic DM/NR, premium HAs relative to basic HAs, and DM/NR features relative to no DM/NR in improving speech understanding and localization performance. Laboratory data also indicated that DM/NR features could improve listening effort and sound quality compared with no features for both basic- and premium-level HAs. For real-world effectiveness, in-situ self-reports first indicated that noisy or very noisy situations did not occur very often in participants' daily lives (10.9% of the time). Although both retrospective and in-situ self-reports indicated that participants were more satisfied with HAs equipped with DM/NR features than without, there was no strong evidence to support the benefit of premium DM/NR features and premium HAs over basic DM/NR features and basic HAs, respectively.ConclusionsAlthough premium DM/NR features and premium HAs outperformed their basic-level counterparts in well-controlled laboratory test conditions, the benefits were not observed in the real world. In contrast, the effect of DM/NR features relative to no features was robust both in the laboratory and in the real world. Therefore, the present study suggests that although both premium and basic DM/NR technologies evaluated in the study have the potential to improve HA outcomes, older adults with mild-to-moderate hearing loss are unlikely to perceive the additional benefits provided by the premium DM/NR features in their daily lives. Limitations concerning the study's generalizability (e.g., participant's lifestyle) are discussed.
| S-EPMC6491270 | biostudies-literature
Project description:BackgroundThe main clinical intervention for mild to moderate hearing loss is the provision of hearing aids. These are routinely offered and fitted to those who seek help for hearing difficulties. By amplifying and improving access to sounds, and speech sounds in particular, the aim of hearing aid use is to reduce the negative consequences of hearing loss and improve participation in everyday life.ObjectivesTo evaluate the effects of hearing aids for mild to moderate hearing loss in adults.Search methodsThe Cochrane ENT Information Specialist searched the ENT Trials Register; the Cochrane Register of Studies Online; MEDLINE; PubMed; EMBASE; CINAHL; Web of Science; ClinicalTrials.gov; ICTRP and additional sources for published and unpublished trials. The date of the search was 23 March 2017.Selection criteriaRandomised controlled trials (RCTs) of hearing aids compared to a passive or active control in adults with mild to moderate hearing loss.Data collection and analysisWe used the standard methodological procedures expected by Cochrane. The primary outcomes in this review were hearing-specific health-related quality of life and the adverse effect pain. Secondary outcomes were health-related quality of life, listening ability and the adverse effect noise-induced hearing loss. We used GRADE to assess the quality of the evidence for each outcome; this is indicated in italics.Main resultsWe included five RCTs involving 825 participants. The studies were carried out in the USA and Europe, and were published between 1987 and 2017. Risk of bias across the studies varied. Most had low risk for selection, reporting and attrition bias, and a high risk for performance and detection bias because blinding was inadequate or absent.All participants had mild to moderate hearing loss. The average age across all five studies was between 69 and 83 years. The duration of the studies ranged between six weeks and six months.There was a large beneficial effect of hearing aids on hearing-specific health-related quality of life associated with participation in daily life as measured using the Hearing Handicap Inventory for the Elderly (HHIE, scale range 1 to 100) compared to the unaided/placebo condition (mean difference (MD) -26.47, 95% confidence interval (CI) -42.16 to -10.77; 722 participants; three studies) (moderate-quality evidence).There was a small beneficial effect of hearing aids on general health-related quality of life (standardised mean difference (SMD) -0.38, 95% CI -0.55 to -0.21; 568 participants; two studies) (moderate-quality evidence). There was a large beneficial effect of hearing aids on listening ability (SMD -1.88, 95% CI -3.24 to -0.52; 534 participants; two studies) (moderate-quality evidence).Adverse effects were measured in only one study (48 participants) and none were reported (very low-quality evidence).Authors' conclusionsThe available evidence concurs that hearing aids are effective at improving hearing-specific health-related quality of life, general health-related quality of life and listening ability in adults with mild to moderate hearing loss. The evidence is compatible with the widespread provision of hearing aids as the first-line clinical management in those who seek help for hearing difficulties. Greater consistency is needed in the choice of outcome measures used to assess benefits from hearing aids. Further placebo-controlled studies would increase our confidence in the estimates of these effects and ascertain whether they vary according to age, gender, degree of hearing loss and type of hearing aid.
| S-EPMC6483809 | biostudies-literature
Project description:Congenital and early onset bilateral sensorineural hearing loss (SNHL) is mainly caused by mutations in numerous genes. The introduction of universal newborn hearing screening (UNHS) has increased the number of infants with mild, moderate, and moderate-to-severe sensorineural hearing loss (SNHL) detected in the first year of life. We aimed to evaluate the audiological features in patients with mild, moderate, and moderate-to-severe SNHL according to genotype. Audiological and genetic data were analyzed for 251 patients and their relatives with congenital bilateral mild, moderate, and moderate-to-severe SNHL. Hearing loss severity, audiogram profile, interaural symmetry, and dynamics of hearing thresholds were analyzed. In this case, 165 patients had GJB2 gene mutations, 30 patients were identified with STRC mutations, and 16 patients had pathogenic or likely pathogenic USH2A mutations. The presence of at least one GJB2 non-truncating variant in genotype led to less severe hearing impairment. The flat and gently sloping audiogram profiles were mostly revealed in all groups. The follow-up revealed the stability of hearing thresholds. GJB2, STRC, and USH2A pathogenic variants were detected in most patients in our cohort and were congenital in most cases.
| S-EPMC9698638 | biostudies-literature
Project description:Background: Age-related hearing loss (presbycusis) is a form of hearing loss in over 60-year-olds and has a negative impact on quality of life. The pathophysiology of presbycusis is multifactorial and is predominately characterised with a loss of speech perception in noise. In the cochlea, auditory filters decompose broadband sound into a series of narrowband output signals, which contains two kinds of temporal information: slow changes in overall amplitude envelope (ENV) and faster variations in temporal fine structure (TFS). TFS is important for recognition of target speech in noise. The main aim of the study is to evaluate the effect of TFS rehabilitation training in participants over the age of 60 years with mild to moderate hearing loss. Methods: A randomised clinical trial conduct on 30 participants with mild (loss of 20-39dB) to moderate (40-69dB) hearing loss, aged between 60 and 75 years old. Participants with conductive hearing loss, abnormal middle ear pathology and central nerve system disease were excluded. Participants were randomly selected to an intervention and control group with a 1:1 ratio. Rehabilitation for the intervention Group are 30-minute sessions three times a week for a total five weeks of vowel consonant vowel words that are used to eliminate ENV and keep only TFS. Word in noise test, binaural TFS test, and Speech, Spatial and Qualities of Hearing Scale scores are performed at the beginning and end of study to evaluate the effect of rehabilitation training. Conclusion: Life expectancy in the elderly has improved, leading to an increased prevalence of age-related diseases including presbycusis. A literature review highlighted that TFS damage is permanent; however, in this study we will attempt to prove that TFS training may lead to speech in noise perception restored. Trial registration: Registry of Clinical Trials, IRCT2019625044006N1 (7 th August 2019).
| S-EPMC7416574 | biostudies-literature
Project description:Dissatisfaction with the sound of one's own voice is common among hearing-aid users. Little is known regarding how hearing impairment and hearing aids separately affect own-voice perception. This study examined own-voice perception and associated issues before and after a hearing-aid fitting for new hearing-aid users and refitting for experienced users to investigate whether it was possible to differentiate between the effect of (unaided) hearing impairment and hearing aids. Further aims were to investigate whether First-Time and Experienced users as well as users with dome and mold inserts differed in the severity of own-voice problems. The study had a cohort design with three groups: First-Time hearing-aid users going from unaided to aided hearing (n = 70), Experienced hearing-aid users replacing their old hearing aids (n = 70), and an unaided control group (n = 70). The control group was surveyed once and the hearing-aid users twice; once before hearing-aid fitting/refitting and once after. The results demonstrated that own-voice problems are common among both First-Time and Experienced hearing-aid users with either dome- or mold-type fittings, while people with near-normal hearing and not using hearing aids report few problems. Hearing aids increased ratings of own-voice problems among First-Time users, particularly those with mold inserts. The results suggest that altered auditory feedback through unaided hearing impairment or through hearing aids is likely both to change own-voice perception and complicate regulation of vocal intensity, but hearing aids are the primary reason for poor perceived sound quality of one's own voice.
| S-EPMC7887686 | biostudies-literature
Project description:We investigated the associations between hearing aids (HA) and the maintenance of cognitive function among community-dwelling older adults with moderate hearing loss. A total of 407 participants aged 60 years or older with moderate hearing loss were recruited from the National Institute for Longevity Sciences, Longitudinal Study for Aging (NILS-LSA). Moderate hearing loss was defined as a pure-tone average of 40-69 dB at 500, 1000, 2000, and 4000 Hz of the better ear, according to the definition proposed by the Japan Audiological Society. Cognitive function was evaluated using the four subtests of the Japanese version of the Wechsler Adult Intelligence Scale-Revised Short Forms (WAIS-R-SF): Information, Similarities, Picture completion, and Digit Symbol Substitution (DSST). A longitudinal analysis of 1192 observations with a mean follow-up period of 4.5 ± 3.9 years was performed. The HA use rate at any time during the follow-up period was 31.4%, and HA users were significantly younger (t-test, p = 0.001), had worse hearing (p < .0001) and higher education (p = 0.001), participated more frequently in the survey (p < .0001), and were less depressed (χ2 test, p = 0.003) than the older adults not using HA. General linear mixed models consisted of the fixed effects of HA use, follow-up time, and an HA use × time interaction term adjusted for age and pure-tone average thresholds at baseline, sex, education, and other possible confounders. HA use showed significant main effects on the scores for Picture completion and DSST after adjustment; scores were better in the HA use group than in the no HA use group. The HA use × time interaction was significant for the Information score (p = 0.040). The model-predicted 12-year slope with centralizing age indicated that the no HA use group showed greater decline over time on Information scores than did HA use group. The slopes did not differ between HA users and non-users for the Similarities, Picture completion and DSST. In conclusion, HA use may have a protective effect on the decline in general knowledge in older adults with moderate hearing loss.
| S-EPMC8513843 | biostudies-literature
Project description:BackgroundTeleaudiology can potentially improve access to hearing healthcare services. Remote hearing aid fittings offer a new mode of service delivery that removes barriers of geography and access to an audiologist. Real-ear measurements (REMs) are the gold standard for hearing aid output verification but require in-clinic appointments. This study will investigate whether remote hearing aid fittings can provide clinically equivalent outcomes when compared to current, in-clinic, best practice guidelines.Research designA repeated measure, double-blinded crossover design will be used. Participants will be randomly allocated to one of two groups to determine order of intervention, balanced for degree of hearing loss.Study sampleSixty adults with mild to moderate hearing loss and at least 1 year of experience with hearing aids will be recruited.Data collection and analysisParticipants will complete two hearing aid fitting protocols, one using an in-clinic fitting process and the other using a remote (at-home) fitting process. In-clinic fittings will include REMs with adjustments to standard (NAL-NL2) prescription targets. The two fitting protocols will then be randomly assigned to participants in a crossover design, so participants and researchers will be blinded to the order of the two fitting protocols. Participants will then have a 4-week period with follow-up appointments for participant-directed gain adjustment. For each fitting protocol, participants will complete objective measurements of final hearing aid output with REMs, speech-in-noise testing, subjective measurements of hearing aid performance, and quality of life measurements. They will then begin an identical period of living with, adjusting, and objective assessment with the other fitting protocol. Data will be analysed as repeated measures with statistical control for potential confounding variables.ResultsData will compare the four-frequency average real-ear aided response (4FREAR) for hearing aids programmed in-clinic and hearing aids programmed remotely, after participant-directed gain adjustments. Secondary measures will assess clinically significant differences in estimated speech intelligibility, hearing-related quality of life, hearing aid benefit, sound quality and preference, and speech-in-noise ability.ConclusionsThis study will inform the development of best practice guidelines for remote hearing aid fittings. If no clinically significant differences are found between in-clinic and remote fit hearing aids, it has the potential to expand teleaudiology initiatives.Trial registrationAustralian New Zealand Clinical Trial Registry, ACTRN12623000028606p . Date of registration: 12 January 2023.
| S-EPMC11010415 | biostudies-literature
Project description:Study objectivesConcomitant patterns of sleep aid use may provide insight for understanding the transition to chronic sleep medication use. Therefore, we sought to characterize the trajectories of concomitant natural product (NP), over-the-counter (OTC), and prescribed (Rx) sleep aid use in a population-based sample over 12-months.MethodsSelf-reported data on the use of NP, OTC, and Rx sleep aids were extracted from a Canadian longitudinal study on the natural history of insomnia (N = 3416, M age = 49.7 ± 14.7 years old; 62% women) at baseline, 6-month, and 12-month. Latent class growth modeling was used to identify latent class trajectories using MPlus Version 7. Participants completed a battery of clinical measures: Ford Insomnia Response to Stress Test, abbreviated Dysfunctional Beliefs and Attitudes about Sleep Scale, Beck Depression Inventory, Insomnia Severity Index and, the Pittsburgh Sleep Quality Index. Associations between class membership and baseline covariates were evaluated.ResultsConcurrent sleep aid use fell into six distinct latent class trajectories over a 12-month period: Minimal Use (74.5%), Rx-Dominant (11.3%), NP-Dominant (6.3%), OTC-Dominant (4.3%), Rx-NP-Dominant (2.4%), and Rx-OTC-Dominant (1.1%). The three latent classes with prominent prescribed agent use predicted greater incidence of healthcare professional consultations for their sleep (p < 0.05), poorer sleep quality (p < 0.001), elevated dysfunctional sleep beliefs (p < 0.001), and sleep reactivity (p < 0.001). Compared to the other four latent classes, clinical profiles of Rx-NP-dominant and Rx-OTC-dominant groups endorsed greater severity across measures.ConclusionsPatterns of sleep aid use may provide insight for identifying individuals who may be vulnerable to inappropriate self-medicating practices.
| S-EPMC8598195 | biostudies-literature