Tag: OTC Hearing Aid Law

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Starkey Issues Statement On FDA Proposed OTC Ruling

Starkey President and CEO Brandon Sawalich has issued a statement regarding the recent proposed ruling by the Federal Food and Drug Administration (FDA) outlining a new category of hearing aids that can be sold over the counter (OTC). 

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Moisture Impact on Hearing Aids: Benefits of Proactive Care by Hearing Care Practices

The effects of moisture on hearing aid repairs and electroacoustic performance are a well-documented and decades-old problem. There are now extremely effective tools available for controlling moisture-related malfunctions and performance issues. This article looks at the Redux system as a dedicated tool for professional drying services in a practice.

Maintaining Consumer Protections for All Hearing Aids

Three years ago on August 18, 2017, what has become known as the “OTC Hearing Aid Act” was signed into law, and we’ve now reached the statutory deadline for proposed rules for this new class of hearing aid. Although FDA is obviously focused on the COVID-19 pandemic, the complexities of federal preemption of state laws related to hearing aids also loom large. To ensure strong consumer protections, HIA conducted exhaustive research of hearing aid laws in the 50 states, identifying five primary areas of consumer protection to flag for FDA.

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Meeting the Challenges of OTC: Who Are Self-fitting Hearing Aids Really For?

What personal and technological factors will influence consumers’ success with self-fitting OTC hearing devices? Researcher Elizabeth Convery, PhD, looks at recent studies suggesting that OTC manufacturers and providers must address a range of important personal and device factors before self-fitting can become a viable option for adults with hearing loss.

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Preparing for OTC Hearing Aids

Unless you’ve been locked in your soundbooth for the past three years, you’re probably well aware that a new class of over-the-counter (OTC) hearing aids will get the green light from the US Food and Drug Administration (FDA) sometime around August 2020, with the notice of proposed rulemaking (NPRM) slated for this November.

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