Hearing Review·Product announcement·OTC / consumer·5h 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.
Hearing Tracker·Product announcement·OTC / consumer·13h 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·4d 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·5d 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·7d 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·7d 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·3w 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)·4w 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·5w 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·5w 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·3mo 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·3mo 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)·3mo 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·3mo 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·3y 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·3y 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·3y 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·3y 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
Starkey Sound Bites·Podcast·OTC / consumer·3y agoLet’s Talk OTCStarkey President and CEO Brandon Sawalich reacts to the FDA's OTC hearing aid regulation and argues that hearing care professionals remain essential in the new OTC landscape on the Starkey Sound Bites podcast.＋Save
Hearing Tracker·Regulatory·Regulatory & legal·4y agoFDA Clears Way for OTC Hearing Aids for People with Mild to Moderate Hearing LossClinicians should prepare to counsel patients on differences between OTC and prescription hearing aids, update practice protocols for managing self-fitted devices, and reassess business models accordingly.＋Save
Hearing Tracker·Regulatory·Regulatory & legal·4y agoFDA Final OTC Hearing Aid Rules Move Forward from OMBOMB clearance is the last federal hurdle before OTC hearing aid rules become law, making this a critical regulatory signal for the entire audiology profession.＋Save
