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Sophono’s Alpha 1 Hearing Aids Get FDA Clearance

May 26th, 2010 Medgadget Editors ENT

Sophono Inc. of Boulder, Colorado has received FDA approval to market the firm’s Alpha 1 line of bone conducting hearing aids, according to Boulder County Business Report. There are three configurations of the Alpha 1 based on the same audio processor that features four channels, 16 frequency bands, and four programs.
Details about the three versions of Alpha 1 from the product page:

The Alpha 1 (M) bone anchored hearing system is comprised of a behind the ear external audio processor which contains a traditional bone conduction vibrator. Attached to the vibrator is a metal plate that is held to the head by a spacer shim. The magnetic spacer is in turn held to the head by a magnetic implant which is screwed to the skull with facial plating screws.

The implant consists of two magnets (similar to cochlear implant magnets) hermetically sealed in a titanium case. The implant is completely passive with no electronic or moving parts and should never need to be replaced,
The surgical implantation requires a small superficial incision in the scalp behind the ear. As soon as the surgical site has healed (3 to 4 weeks) and the swelling has gone down the patient can be fit with the Alpha 1 (M) audio processor.
Alpha 1 (S) attaches magnetically to either a bone conduction head band or to a bone conduction soft band. In this second configuration there are no implanted parts. The Alpha 1 (S) is best for small children until they are old enough for the Alpha 1 (M).
The Alpha 1 (O) is configured with a magnetic attachment that attaches to a proprietary abutment. This abutment attaches directly to the BAHA® flange fixture (Cochlear Corp) to retrofit the flange fixture to accept an Alpha 1.

More at Boulder County Business Report: FDA OKs Sophono’s hearing device…
Product page: Alpha 1…

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Medical technologies transform the world! Join us and see the progress in real time. At Medgadget, we report the latest technology news, interview leaders in the field, and file dispatches from medical events around the world since 2004.

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