US Proposed OTC Hearing Aid Rule Inspired Soundly Founder To ‘Make This Process Easier’
In recent interview, CEO Blake Cadwell talked about Soundly’s business model and outlook for hearing aid marketplace after FDA's pending publication of rule aiming to make the devices more accessible. Firm since June has offered online testing and advice for customers about hearing aids best suited for their needs.
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OTC Sales Of Hearing Aids For Mild To Moderate Loss Allowed Under US FDA Final Rule
After requirement from Congress and push from President Biden, FDA establishes regulatory category for hearing aids to allow US consumers with mild to moderate hearing loss to purchase the devices without a prescription or prior exam.
Making Hearing Aids, Or Are They PSAPs? US FDA Offers Revised Draft Guidance To Help
Revised draft guidance document explains difference between hearing aids, regulated as medical devices, and personal sound amplification products, which aren’t. Guidance published with draft to allow hearing aids to be sold OTC.
No Prescription? No Problem: US FDA Draft Rule Gives Green Light To OTC Hearing Aids
FDA’s proposed rule aims to get more hearing aids into the ears of consumers who need them by allowing OTC sales of the devices. Proposal follows a a July executive order by President Biden directing HHS to issue proposed rules for OTC hearing aids within 120 days.