By Marcello Cherchi, MD PhD
In the past, medical clearance was required for a patient to obtain a hearing aid. Despite the original good intentions of this requirement, it proved to be an unnecessary burden for the vast majority of patients.
Consequently, many states eventually loosened the requirements. In Illinois, the legislature eventually did away with this requirement for patients 18 years and older. This is detailed in:
- Illinois Compiled Statutes: https://www.ilga.gov/legislation/ilcs/ilcs3.asp?ActID=1305&ChapterID=24 (accessed 1/7/2023)
- Illinois Department of Health Hearing Instrument Consumer Protection Program: https://dph.illinois.gov/topics-services/prevention-wellness/vision-hearing/hearing-instrument-consumer-protection-program.html (accessed 1/7/2023)
- Trade websites, such as Hearing Adviser: https://hearingaidadviser.com/do-i-really-need-medical-clearance-to-wear-a-hearing-aid/#:~:text=Medical%20clearance%20for%20the%20use,being%20fitted%20with%20hearing%20aids.&text=In%20most%20cases%20adults%20(anyone,be%20fitted%20without%20medical%20clearance (accessed 1/7/2023)
On 3/21/2017 the United States Congress moved to lift the requirement that hearing aids be approved by the FDA (Food and Drug Administration): https://www.congress.gov/bill/115th-congress/senate-bill/670 (accessed 1/7/2023).
But it was not until 8/16/2022 that the FDA (Food and Drug Administration) explicitly ruled that companies could market over-the-counter hearing aids: https://www.fda.gov/news-events/press-announcements/fda-finalizes-historic-rule-enabling-access-over-counter-hearing-aids-millions-americans (accessed 1/7/2023).
In early October of 2022 the first over-the-counter hearing aids came to the market in the United States. A preliminary analysis suggests that in specific populations (adults with mild to moderate sensorineural hearing loss unrelated to other diagnoses) the efficacy of these over-the-counter hearing aids is comparable to hearing aids fitted by an audiologist (De Sousa et al. 2023).
References
De Sousa KC, Manchaiah V, Moore DR, Graham MA, Swanepoel W (2023) Effectiveness of an Over-the-Counter Self-fitting Hearing Aid Compared With an Audiologist-Fitted Hearing Aid: A Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg 149: 522-530. doi: 10.1001/jamaoto.2023.0376
