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Medical Devices / Submissions and Approvals / Commercial Operations

Parametric Sound Gets FDA OK for Hearing Enhancement Technology

Feb. 21, 2014

Audio products innovator Parametric Sound said Wednesday the FDA has cleared its HyperSound Audio System for people with hearing loss.

The technology employs a thin film to generate an ultrasonic beam of sound that is directed to a specific location. Someone within the beam’s zone can hear immersive 3-D audio similar to wearing a surround sound headset, according to the company.

“HyperSound can be used with anything you put audio through — TV, a radio, stereo system,” said company spokesman David Lowey. Components similar to audio speaker panels are placed on either side of the TV or radio and directed toward the person’s right and left ears.

“The way these panels deliver sound is that it skips over the damage in your ear and you can hear things perfectly clearly,” Lowey said. “It’s not like a hearing aid; it’s more like a consumer speaker.”

In a clinical trial of more than 900 hearing-impaired individuals, 70 percent reported enhanced sound perception and clarity with HyperSound compared with traditional audio systems, Lowey said. The trial was not part of the company’s 510(k) filing.

“We are extremely pleased to have passed the important milestone of FDA clearance,” said Juergen Stark, Parametric’s CEO. “We are hard at work on the next generation of HyperSound products and we are confident they will improve the quality of life for millions of people who suffering hearing impairments.” 

Parametric merged with video game audio manufacturer Turtle Beach in January. Lowey said the new entity weds Parametric’s innovative technology with Turtle Beach’s ability to “bring [products] to market more quickly.” Logistics of a product launch are still being worked out, though purchases won’t require a doctor’s order or exam, he added.

One in five Americans suffer some form of hearing loss. — Meg Bryant

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