Ep. 2022-10 FDA Final Rule on OTC Hearing Aids Series, Part 1: An Overview of OTC Devices With Victor Bray, PhD, and David Akbari, AuD

Hearing Tracker·Regulatory·Regulatory & legal·3w ago

FDA Approves Regeneron's Otarmeni, First Gene Therapy for Genetic Hearing Loss

Audiologists 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.

The Hearing Journal Podcast·Podcast·Regulatory & legal·3y ago

Ep. 2022-10 FDA Final Rule on OTC Hearing Aids Series, Part 3: The Outlook Among the Obstacles With Stephanie Czuhajewski, MPH, CFE

Stephanie 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).

The Hearing Journal Podcast·Podcast·Regulatory & legal·3y ago

Ep. 2022-10 FDA Final Rule on OTC Hearing Aids Series, Part 2: The New Category of Prescription Hearing Aids With Alicia Spoor, AuD

Part 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.

The Hearing Journal Podcast·Podcast·Regulatory & legal·3y ago

Ep. 2022-10 FDA Final Rule on OTC Hearing Aids Series, Part 4: A Call to Action With Kristin Davis, AuD

Dr. 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).

ASHA Voices·Podcast·Regulatory & legal·2y ago

The Non-Compete Agreement Faces An Uncertain Future

ASHA Voices podcast examines the uncertain future of non-compete agreements in employment contracts, including the FTC's recommendation to eliminate them and implications for CSD professionals.

Hearing Review·Regulatory·Regulatory & legal·8d ago

FDA Grants De Novo Classification to TytoCare’s AI Otoscopy Tool

Clinicians 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 ago

Australian-developed Earflo cup receives FDA Clearance for otitis media

A 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.

Starkey Sound Bites·Podcast·Regulatory & legal·4y ago

Our Friends from the Hearing Industries Association Talk Hearing Aid Trends, Surveys and Advocacy

Starkey podcast episode with Hearing Industries Association leaders discussing MarkeTrak data, prescription vs. OTC hearing aids, and legislative advocacy efforts.