Publications by Year: 2026

PURPOSE: To evaluate the safety and tolerability and exploratory efficacy of OTO-413, an intratympanic-administered, sustained release formulation of brain-derived neurotrophic factor (BDNF) in a thermoreversible gel, in participants with speech-in-noise hearing difficulties.

METHODS: This was a single dose, dose-ascending, randomized, double-blind, Placebo-controlled Phase 1/2 study conducted at 7 enrolling clinical sites in the U.S. 110 participants (56% female) enrolled had self-reported speech-in-noise (SIN) difficulties that were confirmed by a SIN test and were randomized to OTO-413 or Placebo. OTO-413 dose range was escalated from 0.01 mg to 1.5 mg within 7 Cohorts. Safety evaluations included monitoring for treatment-emergent adverse events, physical and audiological examinations, and monitoring for plasma BDNF and anti-BDNF antibodies. Exploratory efficacy outcomes included three SIN tests with the Digits-in-Noise Test (DIN), Words in Noise Test (WIN), and the American English Matrix Test (AEMT) and self-reported Patient Global Impression of Change (PGIC).

RESULTS: There were no study drug-related serious adverse events, and no audiometric safety concerns at any OTO-413 dose. Plasma levels of BDNF were comparable to endogenous levels of BDNF and anti-BDNF antibodies were not detected. An exploratory responder analysis indicated a numerical advantage for OTO-413 versus placebo over the three months of observation. Improvement was particularly evident with the WIN at the 0.3 mg dose. No improvement in PGIC was noted.

CONCLUSION: This exploratory study demonstrated that a single intratympanic injection of OTO-413 was safe and well tolerated and provided evidence for a SIN hearing treatment benefit of 0.3 mg OTO-413.

TRIAL REGISTRATION: NCT04129775.

PURPOSE: The purpose of this study was to create a database of Medicaid fee-for-service hearing aid coverage policies for adults over 20 years old from 2003 to 2023 and quantify yearly averages of the share of beneficiaries living with hearing aid coverage benefits.

METHOD: Policy surveillance and data triangulation were used to retrieve and code Medicaid fee-for-service coverage policies. Policy data were combined with a subset of individual-level data from the American Community Survey to estimate the annual share of adult Medicaid beneficiaries over 20 years old residing in states with hearing aid coverage.

SURVEY POPULATION: Policy data were combined with sociodemographic variables from the American Community Survey to estimate the share of adult Medicaid beneficiaries covered by a Medicaid hearing aid coverage policy from 2003 to 2023.

RESULTS: States (N = 32) offered Medicaid hearing aid coverage for adults in 2003. By 2013, that decreased to 27 states but increased to 31 states in 2023. Between 2003 and 2023, four states implemented, four states interrupted, and four states removed coverage. In 2008, 65.4% of adults with Medicaid had hearing aid coverage; this percentage increased to 70.3% by 2023. The longitudinal Medicaid hearing aid policy database is active and continues to be updated.

CONCLUSION: Given the known impacts of untreated hearing loss on quality of life and health, a lack of Medicaid hearing aid coverage for adults may undermine states' health equity goals and public health efforts to promote health over the life course.

SUPPLEMENTAL MATERIAL: https://doi.org/10.23641/asha.32270619.

PURPOSE: This study describes the patient-centered approach to hearing technology selection and fitting of the participants randomized to a best practice hearing intervention as part of the Aging and Cognitive Health Evaluation in Elders (ACHIEVE) study (ClinicalTrials.gov identifier NCT03243422). We evaluated associations between hearing technology with daily hours of hearing aid use and listening and communication goal achievement.

METHOD: The ACHIEVE study (n = 977) was a multicenter, randomized controlled trial designed to test the effect of a best practice hearing intervention versus health education control on cognitive decline over 3 years among older adults with untreated hearing loss. Participants were aged 70-84 years, had adult-onset mild-to-moderate hearing loss, had no previous hearing aid use, and were without substantial cognitive impairment at baseline. Participants randomized to the hearing intervention (n = 490) received a patient-centered comprehensive hearing program including hearing aids with varying feature sets, characterized as standard, advanced, and premium technology levels, and offered at least one hearing-assistive technology (HAT). The Client-Oriented Scale of Improvement (COSI) was used to identify listening needs that guided intervention delivery and was used to assess attainment of hearing-related goals following  10-week intervention period. Hearing aid datalogging was used to measure hours of daily wear. We estimated the association between hearing aid technology level, HATs, hours of wear, and COSI goal attainment using an ordered logistic model adjusting for auditory and sociodemographic characteristics. Proportionality odds assumption was checked for all models.

RESULTS: A total of 459 participants completed the hearing intervention and reported outcomes. Selection of hearing aid technology level and HATs was guided through evidence-based protocol-directed recommendations, with 88 (19%) participants receiving standard; 260 (57%) participants, advanced; and 111 (24%) participants, premium hearing aid technology. Mean daily hours of hearing aid use was high (M = 9.3 hr across all participants) and did not differ between hearing technology (levels or HATs). Participant COSI goals, which included categories such as conversation in noise and in quiet or attending church and/or meetings, improved and were not dependent on technology used. Participants benefited from patient-centered hearing intervention, and there were no statistically significant associations among hearing aid technology level, HATs, hours of use, and change in COSI goals.

CONCLUSIONS: The patient-centered selection of hearing technology used in the ACHIEVE study resulted in high levels of hearing aid and HAT usage, along with positive COSI listening goal attainment for the majority of participants. Carefully assessed and selected technology is needed to meet individual auditory rehabilitation needs.

SUPPLEMENTAL MATERIAL: https://doi.org/10.23641/asha.32069253.

BACKGROUND: Cisplatin is broadly used, but it is nephrotoxic and ototoxic. No large-scale investigation has analysed cisplatin-related ototoxicity while considering quantified renal function, cumulative dose, comorbidities, and modifiable risk factors. Our aim was to fill this knowledge gap.

METHODS: The Platinum Study is a well-characterised multicentre cohort study of cisplatin-treated testicular cancer survivors enrolled 2012-18 in eight academic cancer centres in the USA, Canada, and the UK, with follow-up ongoing. Measures include audiometrically assessed hearing (0.25-12 kHz), real-world speech-in-noise perception, and hearing loss progression. Multivariable analyses evaluated associations of audiometrically-assessed hearing with estimated glomerular filtration rate (eGFR), comorbidities, health-behaviours, and cisplatin dose. Mediation analyses tested direct and indirect eGFR contributions to ototoxicity and eGFR-dose interactions.

FINDINGS: Among 1422 survivors (median age 38 years, IQR 31-47), ototoxicity affected 1061 (75%), and audiometrically-assessed hearing was significantly associated with cumulative cisplatin dose (β = 8.72 per 100 mg/m2, p = 0.0004), reduced eGFR (β = 3.90 per 20 mL/min/1.73 m2, p = 0.043), hypertension (β = 4.06, p = 0.0005), non-White race (β = 3.26, p = 0.014), physical inactivity (β = -0.24 per 1000 kCal/week, p = 0.034), and age (β = 5.21 per 5 years, p < 0.0001). Cisplatin dose significantly interacted with eGFR (p = 0.017); 7.2% (95% CI 0.9-18.8; p < 0.05) of cisplatin's ototoxicity was mediated through reduced eGFR and 5.6% (0.4-16.1; p < 0.05) through interaction effects. Poorer speech-in-noise perception was associated with cognitive dysfunction (β = 1.01, p = 0.026), hypercholesterolaemia without statin use (β = 0.71, p = 0.029), lower education (β = 0.91, p = 0.0098), and hearing loss severity (β = 0.08, p < 0.0001). Hearing loss progression was associated with age (β = 0.30, p < 0.0001), while statin use for hypercholesterolaemia was protective (β = -4.09, p = 0.0048).

INTERPRETATION: Cisplatin's dose-dependent ototoxicity is amplified by its nephrotoxicity, with the dose-response becoming stronger as eGFR worsens. Given age-related declines in both eGFR and hearing, follow-up of cisplatin-treated survivors should monitor both, and include strict control of cardiovascular risk factors. Statin use for hypercholesterolaemia appeared protective against hearing loss progression, suggesting a potential therapeutic intervention for reducing long-term auditory complications in this population.

FUNDING: The National Cancer Institute.

OBJECTIVES: Within the World Health Organization's International Classification of Functioning, Disability and Health, audiometric hearing loss and perceived hearing handicap are related but distinct. Family relational processes may buffer how sensory loss translates into lived burden via support, communication norms, and coping. We tested whether familism or family cohesion moderated the association between hearing loss and perceived handicap among Hispanic/Latino adults.

DESIGN: Cross-sectional analysis of the Hispanic Community Health Study/Study of Latinos and the Hispanic Community Health Study/Study of Latinos Sociocultural Ancillary Study (n = 4889). Hearing loss was defined as better-ear four-frequency pure-tone average (PTA) >25 dB HL. Perceived hearing handicap was measured with the 10-item Hearing Handicap Inventory for Adults/Elderly-Screening version (HHIA/E-S). Adjusted associations of hearing loss with perceived handicap were estimated by multivariable regression. Moderation was tested with continuous interaction terms for familism and family cohesion.

RESULTS: Participants with hearing loss had higher adjusted mean HHIA/E-S scores than those without (6.30 versus 2.91; Geometric Mean Ratio = 2.16, 116% higher; p < .001), indicating roughly double the perceived handicap among those with hearing loss. Although PTA was strongly related to handicap, variability in HHIA/E-S across the range of PTA continuum indicated incomplete correspondence between measures. Across all levels of familism and family cohesion, hearing loss was associated with approximately a two-fold higher perceived handicap (Geometric Mean Ratios ≈ 1.9 to 2.5). No consistent pattern of moderation by familism or family cohesion was noted.

CONCLUSIONS: Audiometric hearing loss was strongly associated with greater perceived handicap, and the magnitude of this association was similar across all levels of familism and family cohesion. Consistent with the World Health Organization's International Classification of Functioning, Disability and Health framework, audiometric thresholds and perceived impact only partially aligned in this cohort, and this relationship was not meaningfully altered by familism or family cohesion. Together, these findings underscore that audiometric thresholds alone do not fully capture the lived impact of hearing loss, as reflected by substantial variability in perceived handicap at similar levels of PTA, and highlight the importance of integrating self-reported experience with clinical history and patient context when identifying need and planning care.