Silicon Investor (SI) -- The First Internet Community

STOCKTALK

We've detected that you're using an ad content blocking browser plug-in or feature. Ads provide a critical source of revenue to the continued operation of Silicon Investor. We ask that you disable ad blocking while on Silicon Investor in the best interests of our community. If you are not using an ad blocker but are still receiving this message, make sure your browser's tracking protection is set to the 'standard' level.

Strategies & Market Trends : The Amateur Traders Corner -- Ignore unavailable to you. Want to Upgrade?

To: Street Hawk who wrote (697)	9/2/2000 4:04:09 PM
From: Tom Hua	Respond to of 19633

SH, Additional noteworthy items regarding SMPX's Soundbridge: 1. Because Soundbridge is implanted in only one ear, the company recommends patients to wear hearing aid in the other ear. 2. No data on device extrusion. 3. Of the 54 patients participated in the clinical trials, major adverse events reported in the U.S. included two patients with clinically significant change in residual hearing, device failure in six patients, and disconnection of the FMT from the incus in one patient. Three minor adverse events also were reported. 4. FDA reviewers also raised concern over the fact that the devices are incompatible with magnetic resonance imaging procedures. "The MRI is being used in more and more procedures and diagnostics, so the fact that [the Soundbridge] is not compatible is an issue for me," FDA Clinical Reviewer/Medical Officer Sidney Jaffee opined. Regards, Tom