Is Eargo a hearing aid or PSAP?

Eargo Hearing

Professional Member

22 September 2017 - 2.22K Views

The FDA defines a hearing aid as a sound-amplifying device intended to compensate for impaired hearing. Eargo is a Class I, FDA-regulated hearing aid intended for individuals with mild to moderate hearing loss. Eargo hearing aids are clinically tested medical devices. They were designed by an ENT doctor with more than 30 years’ experience and rigorously tested by a team of audiologists and hearing professionals before being put into production. Currently, Eargo is being manufactured in an ISO13485 manufacturing facility and all products are inspected by the FDA to ensure they meet all regulatory standards before being delivered to clients.

 

Personal Sound Amplification Products, also referred to with the acronym PSAP or "Personal Sound Amplification Devices," are defined by the U.S. Food and Drug Administration as a “wearable electronic product not intended to compensate for impaired hearing.” They are not hearing aids, which the FDA describes as intended to compensate for impaired hearing. PSAPs are intended for individuals with normal hearing. PSAPs are not intended to make up for impaired hearing. PSAPs are not a medical device and are not regulated by the FDA. They are intended for consumers with normal hearing to amplify sounds in the environment for a number of reasons, such as for recreational activities.

 

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Abram Bailey

Professional Member

08 March 2017 - 2.47K Views

Eargo has been called a hearing aid in the press, but I cannot find any instance of Eargo being called a hearing aid on the Eargo website itself. Also, all FDA-registered hearing aids should be listed in the Global Unique Device Identification Database (GUDID), and I cannot find "Eargo" in the listings. See for yourself: https://accessgudid.nlm.nih.gov/devices/search?query=eargo

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Member
Member 05 August 2018
I have the same question, and can't get an answer out of them, and since their price is the most expensive of any i will have to pass since my insurance won't cover them. that might be the answer to our questions.
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