Importance: Hearing 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.Objective: To 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 Participants: This 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.Interventions: A 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 Measures: The 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).Results: Sixty-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 relevance: In 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 Registration: ClinicalTrials.gov Identifier: NCT05337748

Objectives: The digits-in-noise test (DIN) has become increasingly popular as a consumer-based method to screen for hearing loss. Current versions of all DINs either test ears monaurally or present identical stimuli binaurally (i.e., diotic noise and speech, N_oS_o). Unfortunately, presentation of identical stimuli to each ear inhibits detection of unilateral sensorineural hearing loss (SNHL), and neither diotic nor monaural presentation sensitively detects conductive hearing loss (CHL). After an earlier finding of enhanced sensitivity in normally hearing listeners, this study tested the hypothesis that interaural antiphasic digit presentation (N_oS_π) would improve sensitivity to hearing loss caused by unilateral or asymmetric SNHL, symmetric SNHL, or CHL. Design: This cross-sectional study recruited adults (18 to 84 years) with various levels of hearing based on a 4-frequency pure-tone average (PTA) at 0.5, 1, 2, and 4 kHz. The study sample was comprised of listeners with normal hearing (n = 41; PTA ≤ 25 dB HL in both ears), symmetric SNHL (n = 57; PTA > 25 dB HL), unilateral or asymmetric SNHL (n = 24; PTA > 25 dB HL in the poorer ear), and CHL (n = 23; PTA > 25 dB HL and PTA air-bone gap ≥ 20 dB HL in the poorer ear). Antiphasic and diotic speech reception thresholds (SRTs) were compared using a repeated-measures design. Results: Antiphasic DIN was significantly more sensitive to all three forms of hearing loss than the diotic DIN. SRT test–retest reliability was high for all tests (intraclass correlation coefficient r > 0.89). Area under the receiver operating characteristics curve for detection of hearing loss (>25 dB HL) was higher for antiphasic DIN (0.94) than for diotic DIN (0.77) presentation. After correcting for age, PTA of listeners with normal hearing or symmetric SNHL was more strongly correlated with antiphasic (r _partial[96] = 0.69) than diotic (r _partial = 0.54) SRTs. Slope of fitted regression lines predicting SRT from PTA was significantly steeper for antiphasic than diotic DIN. For listeners with normal hearing or CHL, antiphasic SRTs were more strongly correlated with PTA (r _partial[62] = 0.92) than diotic SRTs (r _partial[62] = 0.64). Slope of the regression line with PTA was also significantly steeper for antiphasic than diotic DIN. The severity of asymmetric hearing loss (poorer ear PTA) was unrelated to SRT. No effect of self-reported English competence on either antiphasic or diotic DIN among the mixed first-language participants was observed. Conclusions: Antiphasic digit presentation markedly improved the sensitivity of the DIN test to detect SNHL, either symmetric or asymmetric, while keeping test duration to a minimum by testing binaurally. In addition, the antiphasic DIN was able to detect CHL, a shortcoming of previous monaural or binaurally diotic DIN versions. The antiphasic DIN is thus a powerful tool for population-based screening. This enhanced functionality combined with smartphone delivery could make the antiphasic DIN suitable as a primary screen that is accessible to a large global audience.

Objectives: The objective of this study was to examine the uptake, user characteristics, and performance of the free WHO smartphone hearing screening test ( hearWHO) as a global hearing health promotion initiative.Method: We retrospectively examined the data of 242 626 tests conducted by adults (> 18 years) on the hearWHO app between February 2019 and May 2021. Test uptake was evaluated by country, WHO world region, test date, and demographics of age and gender.Results: The hearWHO test was completed in nearly every country globally ( n = 179/195), with the greatest uptake seen in China and India. Uptake was greatest in the Western Pacific (32.9%) and European (24.8%) WHO regions. There was a high uptake of tests (44%) by young adults under the age of 30 years. Referral rates were typically higher for older age groups in most WHO regions, except for the African and Eastern Mediterranean regions, where overall hearWHO test uptake was lowest. Most testing (49%) took place in March (2019–2021) coinciding with World Hearing Day (3rd of March) each year.Conclusions: Digital mhealth tools provide many benefits in healthcare, including health promotion, access to information, and services for hearing loss. The hearWHO test was mainly reaching younger adults, positioning it as an important measure for public health advocacy to prevent hearing loss. Since hearing loss is primarily age related, more targeted campaigns or community-based initiatives should be directed toward older adults.

Objective: COVID-19 has been prohibitive to traditional audiological services. No- or low-touch audiological assessment outside a sound-booth precludes test batteries including bone conduction audiometry. This study investigated whether conductive hearing loss (CHL) can be differentiated from sensorineural hearing loss (SNHL) using pure-tone air conduction audiometry and a digits-in-noise (DIN) test. Design: A retrospective sample was analysed using binomial logistic regressions, which determined the effects of pure tone thresholds or averages, speech recognition threshold (SRT), and age on the likelihood that participants had CHL or bilateral SNHL. Study sample: Data of 158 adults with bilateral SNHL (n = 122; PTA_0.5–4 kHz > 25 dB HL bilaterally) or CHL (n = 36; air conduction PTA_{0.5–4 kHz} > 25 dB HL and ≥20 dB air bone gap in the affected ears) were included. Results: The model which best discriminated between CHL and bilateral SNHL used low-frequency pure-tone average (PTA), diotic DIN SRT, and age with an area under the ROC curve of 0.98 and sensitivity and specificity of 97.2 and 93.4%, respectively. Conclusion: CHL can be accurately distinguished from SNHL using pure-tone air conduction audiometry and a diotic DIN. Restrictions on traditional audiological assessment due to COVID-19 require lower touch audiological care which reduces infection risk.

Purpose: The COVID-19 pandemic has accelerated the uptake and scope of telehealth. This study determined the accuracy and reliability of a smartphone digits-in-noise (DIN) test when conducted by adult cochlear implant (CI) recipients in a simulated home environment compared with a clinic setup. Perceptions of remote monitoring using speech-in-noise (SIN) testing were also explored. Method: Thirty-three adult CI recipients between 18 and 78 years of age ( M = 46.7, SD = ±20.4) conducted the DIN test in a simulated home environment and a clinic setup. Test–retest reliability across the two environments and comparisons between test settings were evaluated. A survey explored the perceptions of adult CI recipients regarding remote monitoring and use of the DIN self-test. Results: Mean-aided speech reception thresholds (SRTs) in the clinic and simulated home environment test conditions and clinic and simulated home environment retest conditions did not differ significantly. Mean test–retest SRTs in the clinic and simulated home environment were significantly different ( p < .05). High intraclass correlation coefficient and low standard error of measurement scores reflected good and excellent reliability between test–retest measures and between clinic and simulated home environment measures. Most participants were positive about the possibility of using the DIN test at home to self-assess speech perception, although some test adjustments such as including training items and a less adverse starting signal-to-noise ratio may be required. Conclusion: Adult CI recipients can use the smartphone DIN test to self-assess aided SIN performance in a home environment with accuracy and reliability relatively similar to clinic testing. Supplemental Material: https://doi.org/10.23641/asha.20044418

Importance: With rising interest in over-the-counter (OTC) hearing aids as an alternative to traditional audiologist-fit devices, understanding their long-term efficacy is crucial. However, given the novelty of the US Food and Drug Administration category of OTC hearing aids, minimal evidence currently supports their long-term efficacy.Objective: To compare the long-term self-reported outcomes at 8 months of self-fit OTC hearing aids to the same hearing aids fit by audiologists.Design, Setting, and Participants: Building on a previous randomized clinical trial, this follow-up comparative effectiveness research study reassessed a number of the original participants that were not lost to follow-up. Participants were initially divided into those with self-fit OTC hearing aids and those with audiologist-fit devices. Approximately 8 months after fitting, participants completed self-reported questionnaires. Missing data were addressed through multiple imputation. The original noninferiority trial was conducted at the University of Pretoria in South Africa from April 2022 to August 2022. The current analysis took place between July 7, 2023, to November 20, 2023.Interventions: In the original trial, participants in the self-fit device group received a pair of OTC hearing aids and independently fit them with remote support as needed. The audiologist-fit device group received the same hearing aids fit by a certified audiologist using best practices.Main Outcomes and Measures: The main outcomes were self-reported hearing aid benefit, measured using the Abbreviated Profile of Hearing Aid Benefit (APHAB) and the International Outcome Inventory for Hearing Aids (IOI-HA).Results: Of 64 participants in the trial, 44 participants were included in the extension study (21 [47.7%] in the audiologist-fit group; 23 [52.3%] in the self-fit group). The mean (SD) age of these participants was 63.0 (13.2) years, and 21 (47.7%) were male. At the long-term follow-up, self-fit and audiologist-fit groups showed no significant differences in the APHAB global score (mean difference, 0.02 [95% CI, −7.1 to 7.1]; Cohen d, 0.01 [95% CI, −0.5 to 0.5]) or the IOI-HA total score (mean difference, 1.5 [95% CI, −1.4 to 4.4]; Cohen d, 0.3 [95% CI, −0.2 to 0.8]). From 6 weeks to 8 months, no clinically meaningful group-time interaction was found between groups for the APHAB global score (Cohen d, 0.1 [95% CI, −0.2 to 0.3]), but a significant interaction for the IOI-HA total score was found (Cohen d, −0.6 [95% CI, −0.8 to −0.3]), with the self-fit group generally performing better.Conclusion: This comparative effectiveness research study demonstrated that self-fit OTC hearing aids can offer comparable long-term benefits to audiologist-fit hearing aids for individuals with mild to moderate hearing loss.