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FDA Clears Way for OTC Hearing Aids for People with Mild to Moderate Hearing Loss
The U.S. Food and Drug Administration (FDA) has finalized rules for a new class of over-the-counter (OTC) hearing aids, designed to make amplification more affordable and accessible for adults aged 18 and older with mild to moderate hearing loss. These OTC devices can be purchased directly from stores or online without the need for a medical exam, prescription, or fitting by a licensed professional. The FDA aims to address the high cost of traditional hearing aids and improve access to hearing so...
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FDA Final OTC Hearing Aid Rules Move Forward from OMB
The FDA’s final regulations for over-the-counter (OTC) hearing aids are nearing publication, following completion of the Office of Information and Regulatory Affairs’ (OIRA) review on August 5. The rulemaking process began with the passage of the OTC Hearing Aid Act in March 2017 and the subsequent signing of the FDA Reauthorization Act of 2017 (FDARA), but has been delayed for five years, surpassing the original statutory deadline of August 18, 2020. The delay is attributed to the pandemic’...
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Feeling Off Balance? How Your Inner Ear Can Cause Vertigo
This article discusses vestibular disorders, which affect the balance system involving the inner ear and brain. Symptoms include dizziness, vertigo, vision problems, nausea, fatigue, and hearing issues. These conditions are common, with nearly 40% of U.S. adults experiencing them at some point, and they significantly impact quality of life, especially for older adults and children. The balance system relies on three components: the visual system, proprioceptive system, and the vestibular system i...
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First Look at the Bose Hearing Aid
The article provides an overview of Bose's new FDA-approved self-fitting air-conduction hearing aid, which is designed for individuals aged 18 and older with mild to moderate hearing loss. This innovative product, which resembles Bose's previous "Hearphones," falls into a newly established category of devices that allow users to independently program and customize their settings without the need for professional fitting or pre-programming. The device features a flexible neckband with wired earbud...
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Five Reasons You Should Not Ignore Your Hearing Loss
This article emphasizes the importance of addressing hearing loss, highlighting how ignoring it can lead to significant personal and relational consequences. The author shares their own experience of denying hearing loss for years due to stigma, only later realizing its impact on their life and relationships. They outline five critical reasons why hearing loss should not be ignored: it can push people away, often hides in plain sight, increases the risk of dementia and other health issues, offers...
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Frequency Therapeutics Abandons Hearing Loss Treatment Programs
Frequency Therapeutics Inc. has discontinued its FX-322 and FX-345 programs for sudden or noise-induced sensorineural hearing loss (SNHL) after a Phase 2b trial showed no meaningful improvements compared to placebo. The company will now focus on advancing its multiple sclerosis (MS) treatment program, which aims to induce remyelination. As part of this shift, Frequency plans to reduce its workforce by approximately 55% and extend its financial runway into 2025 to complete the first clinical trial...
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