By Kristina Rebelo
SAN DIEGO -- October 12, 2009 -- A continuous-wear, extended-wear, "invisible" hearing-aid device can be worn by users without inflammation for 90 to 765 days, according to research presented here at the American Academy of Otolaryngology-Head and Neck Surgery Foundation (AAO-HNSF) Annual Meeting 2009.
The device can be worn in populations from 11 years to 100 years of age without incidence of tympanic-membrane injury or osteomyelitis, according to a 2-year retrospective study involving 300 self-selected patients in a private practice who had diagnoses of mild to moderate hearing loss. This is the first study of its kind cleared by the US Food and Drug Administration (FDA), stated investigator Michael Scherl, MD, otolaryngologist, Englewood, New Jersey, speaking here on October 5.
The device is inserted into the bony and soft tissue canal within 5 mm of the tympanic membrane and at least 3 mm medial to the lateral rim of the posterior canal wall. In the study group, there was a reported 9% incidence of transient canal irritation.
"Devices fail after 3 or 4 months and will have to be replaced," noted Dr. Scherl. "If you don't put it in the exact same place, patients can have pain; there's a 'sweet spot' -- and once you find it, you've got to make sure you keep putting it in at that same sweet spot."
Devices in this study were replaced every 30 to 120 days. At the time of extraction and replacement, subjects' ear canals were inspected and observed for signs of infection, inflammation, or tympanic membrane injury.
The study concluded that patients preferred the continuous-wear, extended-wear hearing aid to their prior hearing-aid device 92% of the time. Additionally, they preferred the study device 95% to their former device when using a telephone, and preferred the "invisibility" of the study device 97% of the time from a cosmetic standpoint.
"There was no otitis externa, nor was there the dreaded complication of a bone infection or any other serious complication," concluded Dr. Scherl.
[Presentation title: Safety and Patient Satisfaction With the Lyric Hearing Aid. Abstract SP280]
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