Soundwave Hearing Announces FDA Clearance for its Self-Fitting OTC Hearing Aid
Soundwave Hearing announced FDA clearance of its Sontro Self-Fitting OTC Hearing Aids, designed to improve access to affordable hearing aids.
Soundwave Hearing announced FDA clearance of its Sontro Self-Fitting OTC Hearing Aids, designed to improve access to affordable hearing aids.
The 114-page rules document published today in the Federal Register covers most aspects related to OTC hearing aid manufacturing, electroacoustic requirements, packaging and labeling, returns, and conditions for sale. In an effort to promote more consistency in the regulations and enforcement of hearing aid manufacturing and distribution, the FDA is also proposing several important changes that could affect the industry and state-wide hearing aid dispensing.
The hearing healthcare landscape is changing, but there are several ways to not only survive but thrive in this new age including Medicare Advantage programs and constantly improving direct-to-consumer hearing devices. Part 1 looks at practical pathways for shifting to a fee-for-service (unbundled) business model.