Hearing Review·Product announcement·OTC / consumer·6d agoLegato Frames Now Available in the US, Combining AI Hearing Technology With Prescription EyewearThe integration of OTC hearing aids into prescription eyewear represents a growing convergence of consumer tech and hearing healthcare that could influence patient expectations and referral patterns.
Hearing Tracker·Industry news·OTC / consumer·13d agoMeta Smart Glasses to Get FDA-Cleared OTC Hearing Aid FeatureMeta entering the FDA-cleared OTC hearing aid market via consumer smart glasses signals a major convergence of consumer tech and audiology, with potential to reshape patient acquisition pathways and competitive dynamics for hearing care professionals.＋Save
Hearing Health Matters·Product announcement·OTC / consumer·13d agoMeta AI Glasses to Add FDA-Cleared OTC Hearing Aid FeatureFDA-cleared hearing aid software embedded in mainstream consumer eyewear from a major tech company represents a significant expansion of the OTC hearing aid market and could shift where and how mild-to-moderate hearing loss is addressed.＋Save
Hearing Health Matters·Industry news·OTC / consumer·13d agoMeta AI Glasses to Add FDA-Cleared OTC Hearing Aid FeatureA major consumer-tech brand entering the FDA-cleared OTC hearing aid space with a wearable already in millions of hands could significantly accelerate consumer self-management of mild-to-moderate hearing loss and reshape patient pathways into audiology clinics.＋Save
PU¶PubMed·Journal article·OTC / consumer·2w agoExtremely High Fitting Range and Dangerous Levels Permitted by the Current FDA Guidelines for OTC Hearing Aids and the Need to Consider RECDsAudiologists fitting or advising patients on OTC devices should be aware that current FDA output limits may be unsafe for small ear canals (e.g., children or adults with smaller canals); advocating for RECD-based verification remains best practice.＋Save
Hearing Review·Product announcement·OTC / consumer·2w agoEssilorLuxottica Launches Nuance Audio Plus Hearing GlassesHearing glasses from a major optical brand represent a growing convergence of eyewear and hearing technology that could reshape how mild-to-moderate hearing loss is addressed outside traditional audiology channels.＋Save
Hearing Review·Journal article·Cochlear implants·2w agoStudy Supports Expanding Pediatric Cochlear Implant Candidacy to Younger Ages and Residual HearingThis multicenter evidence supports advocating for earlier cochlear implant referral in infants under 12 months and in children with residual hearing; audiologists should document candidacy discussions in light of evolving evidence, but FDA criteria remain unchanged until...＋Save
Hearing Health Matters·Blog·Cochlear implants·3w agoFDA Expands Pediatric Cochlear Implant Candidacy: What’s Changed?Audiologists evaluating pediatric cochlear implant candidates should review the updated FDA candidacy criteria, as children who were previously ineligible — including younger ages and broader hearing loss profiles — may now qualify for earlier intervention.＋Save
PU¶PubMed·Journal article·OTC / consumer·5w agoFrom policy debate to empirical evidence: a proof-of-concept bibliometric and LLM-assisted abstract-level content analysis of OTC hearing aid research before and after FDA regulationThis is a methods paper demonstrating a bibliometric + AI approach to track OTC hearing-aid research trends; no clinical practice change is indicated, but the mapped evidence gaps may help audiologists anticipate where OTC research is heading.＋Save
Hearing Review·Product announcement·OTC / consumer·7w agoJabra Enhance Launches M Series FDA-Cleared Self-Fitting Hearing AidsNo actionable clinical practice change; this is a DTC product launch that expands the OTC/self-fitting market but introduces no new clinical guidance for audiologists.＋Save
Hearing Tracker·Product announcement·OTC / consumer·7w agoJabra Enhance Launches New M Series of Self-Fitting OTC Hearing AidsThe M Series expands the OTC hearing aid market with a tiered rechargeable lineup, increasing consumer choice and potentially drawing more price-sensitive patients away from clinic-dispensed devices.＋Save
MedWatch·Industry news·OTC / consumer·7w agoSamsung gets FDA approval – takes leap into US OTC marketSamsung's FDA-cleared entry into the OTC hearing aid market signals accelerating big-tech competition that could reshape consumer expectations and referral dynamics across the entire audiology profession.＋Save
PU¶PubMed·Journal article·OTC / consumer·7w agoOver-the-counter hearing aids and integrated health-monitoring sensors: a review of clinical evidence and implementationAudiologists should stay informed about OTC hearing aid clinical evidence gaps and emerging sensor integration, as these developments directly affect patient counseling, fitting workflows, and clinic business models.＋Save
Hearing Practitioner Australia·Industry news·OTC / consumer·8w agoFDA clears Samsung Galaxy Buds Hearing Aid feature using NAL-NL2 for fittingNo immediate practice change is required; however, clinicians should anticipate patient inquiries about Samsung OTC hearing aids and be prepared to discuss their appropriate candidacy (mild-to-moderate perceived loss only) relative to professionally fitted devices.＋Save
Hearing Review·Financial report·Business & finance·8w agoFennec Pharmaceuticals Reports 78% Revenue Jump as Pedmark Demand Reaches Record HighRecord adoption of the only FDA-approved otoprotective agent for pediatric cisplatin patients signals growing integration of hearing-preservation protocols in pediatric oncology, which has downstream implications for audiology referral volume and counseling practices.＋Save
Hearing Review·Regulatory·Cochlear implants·2mo agoAdvanced Bionics Receives FDA Approval for Expanded Cochlear Implant Candidacy Criteria in SSD and AHLClinicians evaluating adults or children with single-sided deafness (SSD) or asymmetric hearing loss (AHL) can now consider Advanced Bionics cochlear implants as an FDA-approved option under expanded candidacy criteria; referral pathways and candidacy checklists should be...＋Save
PU¶PubMed·Journal article·Research (general)·2mo agoRestoration, Not Bypass: Otoferlin Gene Therapy and a New Era in Hearing Loss TreatmentAudiologists should be aware that FDA-approved otoferlin gene therapy (Otarmeni) is now a biological treatment option for patients with confirmed biallelic OTOF-associated SNHL; refer eligible patients to specialized otolaryngology or gene therapy centers for evaluation.＋Save
Hearing Health Matters·Press release·Vestibular·2mo agoSound Pharmaceuticals Completes Enrollment in Phase 3 SPI-1005 Study for Ménière’s DiseaseIf Phase 3 results are positive, SPI-1005 could become the first FDA-approved oral pharmacotherapy specifically targeting Ménière's disease, potentially shifting treatment paradigms for audiologists and otolaryngologists.＋Save
Hearing Health Matters·Press release·Cochlear implants·2mo agoNew Cochlear Osia 3 Sound Processor Brings Rechargeable Technology and Enhanced ConnectivityThe Osia 3 expands the rechargeable bone-anchored hearing system market, which may influence device selection conversations in clinics that fit patients with conductive or single-sided deafness.＋Save
Hearing Review·Regulatory·Regulatory & legal·5mo agoFDA Grants De Novo Classification to TytoCare’s AI Otoscopy ToolClinicians should note this regulatory milestone as the first FDA-cleared AI otoscopy video analysis tool for eardrum bulging detection, but evidence of clinical accuracy and workflow impact in audiology settings is not yet established from this announcement alone.＋Save
Hearing Practitioner Australia·Press release·Regulatory & legal·5mo agoAustralian-developed Earflo cup receives FDA Clearance for otitis mediaA non-surgical, non-pharmacological device option for otitis media with effusion could expand the toolkit available to audiologists and ENTs managing middle ear conditions, particularly in paediatric populations.＋Save
Hearing Review·Industry news·Research (general)·5mo agoFDA Grants Accelerated Approval to Otarmeni Gene Therapy for OTOF-Related Hearing LossAudiologists should be aware that Otarmeni is now FDA-approved for OTOF-related hearing loss and begin familiarizing themselves with candidate identification (genetic testing referral pathways) and post-treatment audiological monitoring protocols, though prescribing authority...＋Save
Hearing Tracker·Regulatory·Regulatory & legal·5mo agoFDA Approves Regeneron's Otarmeni, First Gene Therapy for Genetic Hearing LossAudiologists and ENT teams treating patients with the relevant genetic form of hearing loss should become familiar with Otarmeni's approved indication and refer eligible patients to gene therapy specialists; this is a practice-changing regulatory milestone.＋Save
The Hearing Review YouTube·Podcast·OTC / consumer·2y agoOTC Hearing Aids and How FDA Rules Might Change Hearing Care, with Dr Tom PowersAudiologist Thomas Powers, PhD, and Hearing Review Editor Karl Strom discuss four key aspects of the proposed FDA OTC hearing aid regulations, including output limits and return-for-credit policies.＋Save
The Hearing Review YouTube·Video·Public health & policy·2y agoUpdate from Hearing Loss Association of America (HLAA) Executive Director Barbara KelleyHLAA Executive Director Barbara Kelley updates listeners on the organization's advocacy work across FDA, FTC, FCC, HHS, NIDCD, and other hearing healthcare stakeholders.＋Save
Starkey Sound Bites·Podcast·Professional practice·3y agoGrowing Opportunities for Hearing Healthcare ProfessionalsStarkey CEO Brandon Sawalich discusses growing opportunities for hearing healthcare professionals in a post-FDA OTC ruling environment during Better Hearing and Speech Month.＋Save
The Hearing Journal Podcast·Podcast·Regulatory & legal·4y agoEp. 2022-10 FDA Final Rule on OTC Hearing Aids Series, Part 2: The New Category of Prescription Hearing Aids With Alicia Spoor, AuDPart 2 of a 4-part Hearing Journal Podcast series on the FDA OTC hearing aid final rule, focusing on the new prescription hearing aid category with Dr. Alicia Spoor, AuD.＋Save
The Hearing Journal Podcast·Podcast·Regulatory & legal·4y agoEp. 2022-10 FDA Final Rule on OTC Hearing Aids Series, Part 1: An Overview of OTC Devices With Victor Bray, PhD, and David Akbari, AuDDrs. Victor Bray and David Akbari provide an overview of the FDA final rule on OTC hearing aids and outline implications for the audiology profession (Part 1 of 4-part series).＋Save
The Hearing Journal Podcast·Podcast·Regulatory & legal·4y agoEp. 2022-10 FDA Final Rule on OTC Hearing Aids Series, Part 4: A Call to Action With Kristin Davis, AuDDr. Kristin Davis discusses how audiologists can proactively respond to and prepare for the implications of the FDA final rule on OTC hearing aids (Part 4 of 4-part series).＋Save
The Hearing Journal Podcast·Podcast·Regulatory & legal·4y agoEp. 2022-10 FDA Final Rule on OTC Hearing Aids Series, Part 3: The Outlook Among the Obstacles With Stephanie Czuhajewski, MPH, CFEStephanie Czuhajewski discusses current and potential obstacles audiologists face following the FDA's final rule on over-the-counter hearing aids (Part 3 of 4-part series).＋Save
