fda otc hearing aid letter

HHTM Hearing News Round-up: This Week’s Highlights

It’s the middle of summer, so grab an iced tea (or an Arnie Palmer, if that’s your thing) and catch up on some industry news.


FDA States that OTC Category Does Not Yet Exist


The Food and Drug Administration (FDA), which regulates hearing devices, issued a letter to hearing aid manufacturers on July 24 stating that the over the counter hearing aid category does not exist.  The letter serves as a reminder that the FDA has until August 18, 2020 to publish proposed regulations by August 18, 2020, to consider public comments, and then to publish final regulations within 180 days of that August 2020 date. Until that time, as the letter clearly states,

“no products that are claimed to address hearing loss are, or can claim to be, OTC hearing aids.”

The letter cites section 709 of the FDA Reauthorization Act of 2017 (FDARA). The FDA letter can be read here.


Sound Used to Treat Dementia


Researchers in Japan, using ultrasound, showed that cognitive function in mice can be restored. They conclude that ultrasonic therapy could be applied in humans. The researchers found that applying low-intensity pulsed ultrasound to the whole brain of the mice improved blood vessel formation and nerve cell regeneration without having obvious side effects. Given the prevalence of dementia in the global aging population, ultrasonic therapy for dementia could hold a great deal of promise.

To read more about this potentially groundbreaking therapy, see this recent Science Daily article.


Poor Sleep Associated with Alzheimer’s


Another recent article, this one in ENT Today, also examined issues related to dementia and Alzheimer’s disease. The significant role insufficient or poor sleep may have on the development of Alzheimer’s disease was addressed by the American Academy of Sleep Medicine (AASM) who issued a health advisory warning on the topic.


According to the warning, which is supported by several peer reviewed studies, years of chronic sleep loss or poor sleep may contribute to the gradual accumulation of beta-amyloid, a protein in the brain linked to Alzheimer’s disease.


This toxic material, linked to impairment of learning and memory, may be flushed out when sufficient sleep is achieved consistently. Additionally, AASM also stated that when sleep apnea remains untreated, sleep disturbance, low oxygen levels, or other adverse effects such as increased beta-amyloid may contribute to the progression of Alzheimer’s disease. The report can be found at the ENT Today website.

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