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…
