Acousticon receives FDA 510K clearance for ACAM-5 integrated hearing loss assessment system

Apr 27 2011

Acousticon Inc., the US subsidiary of Acousticon GmbH announced today that they have received FDA 510K clearance for ACAM-5®, a German-engineered, stand-alone system containing an audiometer integrated with Real Ear Measurement (REM), and Hearing Instrument Test (HIT) modules. The ACAM-5® helps audiologists and other hearing professionals 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”

Stand-alone ACAM-5® system with advanced technologies and modular components

"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. "In Germany, hearing professionals report that the ACAM-5® improves 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. This has resulted in fewer customer complaints and greater customer satisfaction. Some users have reported that in almost 80% of cases, patients noted a perceptible improvement in their ability to understand speech even when their hearing aid was fitted using another method."

The ACAM-5® is a fully integrated software and hardware system that offers all of the benefits and features of other systems available in the United States, plus additional capabilities no other product can offer in one stand-alone system. The ACAM-5® is modular in design and takes the guess-work out of the fitting process. It does this through a combination of technologies and procedures including TruTarget™ and AccuFit™. TruTarget™ is Acousticon's proprietary application of loudness scaling 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.

"What makes the ACAM-5® so unique, and so valuable to patients and hearing professionals, is that it allows the practitioner to accurately assess the patient's individual psychoacoustics and hearing aid needs, not just an estimate based on the averages of other people. This allows for a fitting designed to bring the patient's hearing as close to 'normal' as possible."

ACAM-5 introduced at AudiologyNOW!

Acousticon USA, a newly incorporated division of Acousticon Horsysteme GmbH, introduced ACAM-5® to US audiologists and hearing professionals at AudiologyNOW! in Chicago IL, April 6-9, 2011.

German-engineered system now available in the US

The ACAM® system, initially developed in Germany in 1987 by audiologist Harald Bonsel, was the world's first fully integrated, all-in-one hearing aid fitting system. Some have referred to it as the "most full featured" hearing aid fitting system on the market. Now, after 25 years of research, refinement and successful use in Europe, the ACAM-5® is available to leading audiologists and hearing aid professionals in the United States.