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Bose Launches First FDA-Cleared DTC Hearing Aids

by Jasmine Pennic 05/12/2021 Leave a Comment

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What You Should Know:

– Bose is entering the digital health market launch of Bose SoundControl Hearing Aids – the first FDA-cleared, direct-to-consumer hearing aid.   

– Weighing 3 grams each, the new SoundControl™ Hearing Aids are developed for adults with perceived mild to moderate hearing loss. Eight batteries are included in total, and one lasts up to four days when used 14 hours daily. They can be replaced wherever hearing aid batteries are sold and easily changed via a durable door on the exterior.

– Paired with the revolutionary Bose Hear app, users can fit, program, and control a SoundControl Hearing Aid for clinically proven, audiologist-quality results — without a doctor visit, hearing test, or prescription. And they can make setting adjustments themselves, in real-time and real-world environments, without assistance from a healthcare professional.

Clinical Study Outcomes/Results

In a clinical study with researchers at Northwestern University, Bose CustomTune technology yielded results that were as good if not better than those achieved by traditional prescription-fitting methods used by audiologists. The study’s participants were split into two groups with similar levels of hearing loss. One group used Bose CustomTune technology to self-tune a device, the other had the same device fit and tuned by an audiologist. Participants using Bose CustomTune technology reported being more satisfied with their sound quality than those whose devices were tuned by a hearing health professional.

Pricing & Availability

SoundControl Hearing Aids come with a 90-day risk-free trial, dedicated product support, and are available at a fraction of the cost of most conventional hearing aids. They will be sold directly from Bose for $849.95 starting May 18th in five states: Massachusetts, Montana, North Carolina, South Carolina, and Texas — with nationwide availability to follow.

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Tagged With: FDA, FDA Clearance

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