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March 01, 2021 05:00am
Nearly two-thirds of individuals with severe hearing loss are unable to afford hearing devices.
Increasing technology may make it possible to provide elderly patients with affordable OTC hearing aids.
Samsung, Bose Corp, and Panasonic Corp are some of the companies reportedly working to release hearing aids that can connect wirelessly to smartphones, televisions, tablets, and other gadgets, according toKaiser Health News.
Richard Einhorn, board member of the Hearing Loss Association of America, toldKHNthat he predicts the devices will be used widely by older patients, similar to the current widespread use of earbuds by younger individuals.
In December 2016, former FDA Commissioner Dr Robert Califf, said the agency planned to take necessary steps to propose the modification of the agency’s regulations in order to create a category of OTC hearing aids.
The Federal Trade Commission announced last week its plans to hold a major meeting in April regardinghearinghealth care.
Under the new Trump administration, it remains uncertain if the agency’s priorities will change. Regardless, technology is continuing to develop rapidly, according toKHN.
More than 40% of individuals 60 years or older have mostly mild to moderate hearing loss. But this number jumps to 80% in individuals 80 years or older.
Despite these numbers, only 20% of individuals with some degree of impairment use hearing aids. The most common reasons include the high cost—–with 1 pair of hearing aids averaging almost $5000––lack of health insurance coverage, stigma, denial, and difficulty navigating the hearing health system.
Older adults with mild to moderate hearing loss—–including baby boomers––are expected to be the primary marketing target for these new technologically advanced hearing aids.
Both the President’s Council of Advisors on Science and Technology and the National Academics of Sciences, Engineering, and Medicine support expanded access to low-cost, over the counter hearing devices.
The organizations cited research linking hearing loss to cognitive decline, depression, onset of dementia, poor physical function, and social isolation, according toKHN.
Previously, the FDA required that adults be examined by a physician before purchasing a hearing aid, or sign a waiver noting that they did not want to take this step. Last month, however, the FDA eliminated these requirement for individuals over the age of 18 years.
In the National Academies of Sciences’ panel on hearing health, experts said that the rule provided no clinically meaningful benefit and ran the risk of discouraging patients from seeking care. Approximately 60% to 95% of the time, adults signed the waiver rather than seeing a physician.
Despite the changes, limits remain on access to hearing aids. According toKHN, the distribution of these devices are restricted in all states to certified audiologists, device specialists, and physicians. Additionally, some states still require medical evaluations.
In an effort to increase competition, lower costs, and expand access to hearing devices, Sens Charles Grassley (R-Iowa) and Elizabeth Warren (D-Mass) said they would soon introduce new legislation endorsing OTC hearing aids sold without the restrictions.
The senators plan to introduce the legislation in a new congressional hearing that will the FDA to issue regulations that ensure the safety and efficacy of the devices.