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Soundtec Direct System Priced To Offset Poor Reimbursement Environment

This article was originally published in The Gray Sheet

Executive Summary

Soundtec will sell its Direct System implantable middle ear hearing device at a competitively low price in an effort to counterbalance the potential lack of reimbursement from third-party payers.

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Soundtec Direct System

Ear canal sound processor for the middle ear implantable hearing device gains FDA go-ahead. The magnet-based component can be implanted in less than 30 minutes in an outpatient procedure. The ear canal processor is intended to be cosmetically more pleasing than the behind-the-ear processor that was available when the Direct System gained PMA approval in September 2001 (1"The Gray Sheet" Oct. 1, 2001, p. 20)...

Soundtec Direct System

Ear canal sound processor for the middle ear implantable hearing device gains FDA go-ahead. The magnet-based component can be implanted in less than 30 minutes in an outpatient procedure. The ear canal processor is intended to be cosmetically more pleasing than the behind-the-ear processor that was available when the Direct System gained PMA approval in September 2001 (1"The Gray Sheet" Oct. 1, 2001, p. 20)...

Soundtec Direct System

Implantable hearing device PMA approved by FDA Sept. 7 for use in adults who have a moderate-to-severe sensorineural hearing loss and who desire an alternative to an acoustic hearing aid. Postapproval reports must include: clinically significant changes in residual hearing to the implant ear; alleged complications due to ossicular erosion; and device extrusions. The Oklahoma City firm's device consists of a speech/sound processor worn in or behind the ear and a tiny rare-earth magnet implanted in the middle ear in a procedure taking 25 minutes that be performed under local anesthetic

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