Over-the-Counter Hearing Aids Launched
After the FDA finalized its ruling in August, a medical device company officially launched its over-the-counter hearing aids.
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- On October 17, 2022, Lucid Hearing officially launched its line of over-the-counter hearing aids. The launch follows an FDA ruling earlier this year that allowed for the over-the-counter sale of hearing aids. The devices will launch at Sam’s Club locations across the country.
"We're ready and excited to offer consumers affordable and accessible hearing aids that comply with all FDA regulations and provide those with hearing impairments a broad range of designs and product features," said Lucid Hearing President and COO Jason Kidd. "Our technology for these devices has been in the making for years and is based on research done in conjunction with the University of Texas at Dallas (UTD), a top audiology research university,” said the company in the press release.
These devices are only available to people with mild-to-moderate hearing loss and no longer require visiting a trained healthcare professional. Despite not needing a clinical diagnosis, experts recommend a hearing test for the best patient outcomes.
The company will offer free hearing tests at multiple locations for patients choosing to opt for a hearing test. The devices themselves market for between $199.99 and $1,699.99.
“Executive Vice President of Research and Development Bennett Griffin noted that the company's OTC hearing aids will offer numerous features, including wireless streaming and varied styles, including discreet in-ear offerings. He added that Lucid's significant investment in scientific and innovative pre-set programs developed as a result of the UTD audiology research offers a unique advantage in that they will cover the vast majority of consumers' perceived mild to moderate hearing loss needs,” stated the press release.
According to the National Institute on Deafness and Other Communication Disorders, nearly 2.8 million Americans need a hearing aid. However, only about 20% of that population actually gets a hearing aid. Not requiring a prescription may eliminate one barrier preventing people from accessing these medical devices. Providers may consider informing patients of this option if they are not in the position to see an otolaryngologist for a formal diagnosis. However, they are urged to caution patients that these hearing aids are not meant for people with severe hearing loss.
