NEWARK, Calif — The InSound Medical Lyric deep-fitting disposable hearing aid has received from the Food and Drug Administration (FDA) an extension of its indication for use statement so that appropriately trained audiologists and dispensing professionals, in addition to ENT physicians, can place the new hearing device in a patient's ear canal. Previously, only ENTs were allowed to place the device in the ear canal.

Although the new indication opens the door to audiologists' and dispensing professionals' placement of the device without medical supervision, InSound Medical's VP of Marketing Susan Whichard notes that the company's strategy is to work first with those audiologists and dispensing professionals who maintain close professional relationships with ENTs. She says that the company intends to transition  changes in the placement of the device in appropriate stages. For example, a dispensing professional might decide to work with an ENT when performing new Lyric fittings, then progress to doing the majority of the replacement fittings and/or new fittings him/herself.

However, she notes that one of the benefits of offering Lyric is the opportunity to work closely with ENTs in a respectful environment, where the ENTs can appreciate the services afforded by audiologists and dispensing professionals, thereby establishing excellent working relationships that would ultimately lead to more robust referral networks—something that the hearing care field has lacked in the past.  “ENTs traditionally have not been afforded the opportunity to see the results of a quality hearing aid fitting,” says Whichard. “So when they can view first-hand the great improvement that this device offers, it becomes a wonderful tool and a real motivator for them, with the net effect of bringing more, or at least a renewed, respect for our profession.”

As reported in the April 24 edition of The Insider, Lyric was premiered at an American Academy of Audiology (AAA) convention seminar in Charlotte by Whichard and Mark Sanford, MS, who dispenses the device in his practice. It is a disposable deep-fitting device that is inserted completely into the ear canal to a depth about 4 mm from the tympanic membrane (TM).

Lyric is marketed as the first 100% invisible extended-wear hearing solution that isn’t a cochlear or middle-ear implant. Taking advantage of the device’s extremely close proximity to the TM, the device is designed to provide improved sound quality, hassle-free 24-hour operation, and unbeatable cosmetics. The deep-fitting programmable device is also said to provide less distortion, improved sound localization, better protection from wind noise, more security/retention of fit, and complete ease of use with telephones. Lyric is disposable and is discarded after 120 days or when the battery ceases to function.

In late April, Lyric was being used by about 500 hearing-impaired people, and InSound Medical reports that it plans a controlled regional product rollout—currently about 15 hearing care offices in California, New Jersey, and Florida—with possibly 80-100 practices offering the device by the end of 2008. Patients pay for the device on a subscription basis in a range of about $1450-$2000 per year per ear.

More information and a video of the device can be found by clicking here.

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Lyric Deep-Fitting Disposable Device Profiled by NY Times. April 24, 2008 HR The Insider.

InSound XT Extended-Wear Hearing Device Approved by FDA; Field Trials Commence. January 2003 HR News.