An all-in-one hearing aid fitting system rooted in German engineering has received 510(k) clearance from the U.S. Food and Drug Administration.
Acousticon, the Durham, North Carolina-based American subsidiary of German firm Acousticon GmbH, announced Tuesday that the FDA has cleared its ACAM-5 system. ACAM-5 combines hardware and software into a system that helps audiologists understand the severity of a patient’s hearing loss and optimize the fit of a hearing aid to the hearing needs of each patient.
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Acousticon USA CEO Robert Keefer did not return a phone message seeking comment. But in a prepared statement, Keefer said that German hearing professionals who have been using the system report improved results in fitting patients with hearing aids. Keefer is also a partner at business development firm Technology Commercialization Group, which has offices in Durham and Germany. TCG works with medical device, diagnostic, biopharmaceutical and biotechnology companies to enter new markets.
ACAM-5 was first developed in 1987 by German audiologist Harald Bonsel, who is now CEO of Acousticon GmbH. Acousticon says that the system has since been refined based on its use in Europe for nearly 25 years. With the FDA clearance, the company will now market the product to audiologists and hearing aid professionals in the United States.
Acousticon says its system stands apart from other hearing aid systems through a proprietary application of loudness scaling to determine each patient’s target curve for hearing aid fitting. The technology allows for a personalized hearing aid fit that doesn’t rely on the hearing averages of other people.
Acousticon further describes its technology in this promotional video: ACAM-5 from Acousticon USA on Vimeo.
