Durham, NC — Acousticon Inc has announced today that it has received FDA 510(k) clearance for its ACAM-5, a German-engineered, stand-alone diagnostic hearing device that contains an audiometer integrated with Real Ear Measurement (REM) and Hearing Instrument Test (HIT) modules.

The ACAM-5 is designed to help audiologists and other hearing professionals to better understand the scope and depth of the patient’s hearing loss, and optimize their hearing aid’s performance, all in one desktop system.

“We are excited to bring this new product to the audiologists and hearing impaired population of the United States,” said Robert Keefer, CEO of Acousticon USA, a division of Germany-based Acousticon GmbH.

In the press statement, Keefer also reported that German, hearing professionals using ACAM-5 have improved their ability to counsel patients on which hearing aids to buy and objectively helps them determine the best way to ensure the hearing aid meets the exact needs of patients, which has led to fewer customer complaints and greater customer satisfaction.

The ACAM-5 is a modular system that includes a combination of technologies and procedures, including TruTarget and AccuFit.

TruTarget is Acousticon’s proprietary application of loudness scaling, which is used to determine a patient’s own target curve for the hearing aid fitting. AccuFit is the company’s brand of percentile analysis, which helps the hearing professional fit the hearing aid in a way that the patient can hear every dynamic of very complex sound signals like human speech.

SOURCE: Acousticon USA