FDA

The FDA and HearSource’s Affordable Hearing Aid Distribution Business Model Efforts

One of the major impediments to the purchasing of hearing aids for many is cost. Recognizing this impediment to the hearing aid consumer, the Food and Drug Administration has announced changes to the laws, rules and regulations governing the dispensing of hearing aids in the United States.

Purchasing hearing aids by mail, online, or via call center is legal, if the hearing aids are properly listed with the Food and Drug Administration (FDA). All HearSource hearing aids are listed with the FDA.

The FDA regulates the hearing aid industry and HearSource’s business model exists today because of the regulatory actions the FDA has taken to promote the availability and accessibility of affordable hearing aid devices to the general public.

In the past, the FDA did require a medical waiver to be signed by the consumer prior to the purchase of hearing aids from ANY hearing aid dispenser including local offices, direct mail or online hearing aid providers. Licensed Hearing Aid Dispensers are still required to be on staff. HearSource has these experienced and licensed hearing aid professionals on staff.

In December of 2016, the FDA discontinued the medical waiver requirement and in August of 2017, President Trump signed into law the Over-the-Counter (OTC) Hearing Aid Act, that allows persons over the age of 18 years, to access OTC hearing aids without being seen by a  hearing care professional. The FDA is now working on the final wording, rules, and regulations concerning this legislation.

HearSource offers affordably priced hearing aids with the much needed aftercare and support associated with hearing aid wear.

For more information visit HearSource.com

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