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A new proposal from the US Food and Drug Administration (FDA) and recent findings linking hearing impairment to dementia and a thyroid eye drug led to this week's top trending clinical topic (see Infographic below).
The move from the FDA comes nearly 5 years after Congress passed a law allowing over-the-counter hearing aid sales. Those with severe hearing loss will still be required to see a doctor or specialist to acquire a device. "This allows us to put hearing devices more in reach of communities that have often been left out. Communities of color and the underserved typically and traditionally lacked access to hearing aids," Xavier Becerra, secretary of the US Department of Health and Human Services, said at a news briefing. Around 38 million Americans aged 18 years or older report having hearing trouble, says Janet Woodcock, MD, acting commissioner of the FDA. But she says only about 20% of people who could benefit from hearing aids are using them, with barriers to access being a major factor.
The FDA says it's unclear exactly when the new products will be in stores, but finalizing the ruling is a top priority. For new products, the ruling is expected to go into effect 60 days after it is finalized. Current products would have 180 days to make changes, according to the FDA. The American Academy of Audiology said in a statement that it is reviewing the proposed rules and will provide comments to the FDA. In July, Angela Shoup, PhD, a professor at the School of Behavioral and Brain Sciences at the University of Texas at Dallas, wrote to Becerra with concerns about over-the-counter (OTC) sales of hearing aids. "While we certainly support efforts to lower costs and improve access to hearing aids, we have grave concerns about the oversimplification of hearing loss and treatment in the advancement of OTC devices," she wrote.
In a study presented in October at the American Thyroid Association 2021 Meeting, hearing loss was linked to the thyroid eye disease drug teprotumumab (Tepezza). A high proportion of patients treated with the drug report signs of hearing dysfunction after three or four infusions, with nearly half having symptoms that appear to be persistent. Teprotumumab is the first drug specifically approved for the treatment of thyroid eye disease and was cleared by the FDA. Reports prior to its approval described hearing dysfunction in about 10% of patients. In the recent, small, single-center analysis, as many as 22 of the 27 patients (81.5%) reported the development of new subjective otologic symptoms after beginning treatment.
That study comes in the wake of findings over the summer that hearing loss may be a potentially modifiable risk factor for the development of dementia. The new study used a measure of impairment to assess an individual's ability to hear speech in the presence of background noise. Results showed that after adjustment for sociodemographic, lifestyle, and health-related factors, both insufficient and poor speech-in-noise hearing were associated with a significantly increased risk for dementia. Poor hearing was linked to a 61% increase in dementia (hazard ratio [HR] = 1.61; 95% CI, 1.41-1.84), and insufficient hearing was linked to a 91% increase (HR = 1.91; 95% CI, 1.55 – 2.36) relative to normal hearing.
Hearing loss was also recently found to be associated with poor physical function. Older adults with the impaired hearing tend to have poorer physical function, less walking endurance, and faster declines in physical function compared with older adults with normal hearing, according to a new study. Hearing loss is associated with slower gait and, in particular, worse balance, the data suggest. Given these potential serious associations, the FDA's proposal was welcomed by many, leading to this week's top trending clinical topic.
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Cite this: Ryan Syrek. Trending Clinical Topic: Hearing Impairment - Medscape - Nov 05, 2021.