[Dysphagia] Use of e-stim for speech and swallowing disorders

[ldcrabtr at pmt.org (Leslie D. Crabtree)]

The FDA letter enclosure states:

"Indications for Use:
       Muscle re-education by application of external stimulation to the 
muscles necessary for pharyngeal contraction."

This appears to be directly stating that it is approved for use in the 
treatment of dysphagia.  You are correct in saying that it was approved 
because the "device is substantially equivalent (for the indications for use 
stated in the enclosure) to legally marketed predicate devices...". 
However, I do not believe any other device on the market specifically 
identifies these muscles.  I would be happy to hear if another device does.

L. Crabtree, MS, CCC-SLP

----- Original Message ----- 
From: <Drirenect@aol.com>
To: <kevdlambert@comcast.net>; <Dysphagia@b9.com>
Sent: Wednesday, March 01, 2006 2:13 PM
Subject: Re: [Dysphagia] Use of e-stim for speech and swallowing disorders


> If you check the FDA letter you find that it is NOT approved for 
> ysphagia  -
> it is approved because it is no different from other devices already on 
> the
> market. The letter is available on the FDA website.
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