Hearing Review·Regulatory·Regulatory & legal·8d 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.
Hearing Practitioner Australia·Press release·Regulatory & legal·13d 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)·2w 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·3w 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·1y 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·1y 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
