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Bose Launches First FDA-Cleared DTC Hearing Aids

Bose Launches First FDA-Cleared DTC Hearing Aids | healthcare technology | Scoop.it

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. – 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.

 

read more at https://hitconsultant.net/2021/05/12/bose-launches-first-fda-cleared-dtc-hearing-aids/

 

 

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Better Hearing Through Bluetooth

Better Hearing Through Bluetooth | healthcare technology | Scoop.it

A new generation of products that utilize the latest wireless technology are offering promising alternatives for some people with hearing loss.


The devices which are classified as a personal sound amplifier product, or P.S.A.P., are designed to amplify sounds in a recreational environment.


Unlike hearing aids, P.S.A.P.’s are exempt from Food and Drug Administration oversight and can be sold as electronic devices directly to consumers, with no need to see a physician before buying one. They come with a range of features and vary widely in price.


And while some hearing professionals have long cautioned against the devices, citing their unreliability and poor quality, many also say that a new generation of P.S.A.P.s that utilize the latest wireless technology are offering promising alternatives for some people with hearing loss.


There are limitations to who can benefit. “A personal sound amplifier is really designed for patients who have normal or near normal hearing. It’s not really designed as a hearing device to address significant sensorineural hearing loss,” said Bettie Borton, the president of the American Academy of Audiology. It is also important that those with hearing loss be screened for potentially serious medical problems that may be causing the problem.


more at http://well.blogs.nytimes.com/2014/01/15/better-hearing-through-bluetooth/

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