RE: [bhNEWS] FDA Green Flags Advanced Bionics Implant for Return to Market

[Guest guest]

Update: FDA Approval for Return to Market in United States

****Update: FDA Approval for Return to Market in United States****

Advanced Bionics HiRes 90K Cochlear Implant September 13, 2011

Advanced Bionics is pleased to announce that we have received approval from

the FDA to resume distribution of the HiRes 90KTM implant in the United

States. Please note that our ability to provide implants to cochlear implant

centers will vary due to limited supply in the initial weeks of AB’s

re-entry to the US market. Your local Advanced Bionics representative will

keep you informed as we prepare to resume the distribution of HiRes 90K

implants to your centers.

Finally, we would like to provide you with an update on the status of AB’s

voluntary HiRes 90K implant recall. Our investigation continues to show that

of the more than 28,000 implanted HiRes 90K devices, only two (0.007%)

explanted devices have been confirmed to have the issue. You can trust that

AB will stand by our commitment to putting patients first.

We would like to thank you for your patience, understanding, and support

while we resolved the HiRes 90K implant recall and return to markets across

the globe. AB remains firmly committed to making a difference in the lives

of those impacted by hearing loss and we look forward to continuing this

important mission in partnership with you.

Sincerely,

Gerhard Roehrlein, PhD

CEO and CTO Advanced Bionics, LLC

………………

From: bhNEWS [mailto:bhNEWS ] On Behalf Of

MacPherson

Sent: Tuesday, September 13, 2011 11:39 AM

bhNEWS

Subject: [bhNEWS] FDA Green Flags Advanced Bionics Implant for Return to

Market

Press release, Sonova - September 13, 2011

---------------

Sonova announces FDA approval for U.S. market re-entry of the Advanced

Bionics HiRes 90K cochlear implant

Stäfa (Switzerland), 13.09.2011 – Sonova is pleased to announce the

immediate market re-entry of the Advanced Bionics HiRes 90K cochlear implant

in the United States. In recent months, Advanced Bionics (AB) received

approval from several other regulatory bodies, including Health Canada and

the European Notified Body (TÜV), to resume distribution of the HiRes 90K

cochlear implant to Canada and countries accepting the CE Mark. With the

approval of the Food and Drug Administration (FDA), Advanced Bionics can

resume distribution in the United States and re-enter all markets worldwide.

..............

Complete release:

http://www.sonova.com/en/investors/news/Pages/fdaapproval20110913.aspx

[Guest guest]

Great to know that they got FDA approval for distribution in the US again. Now

if only the FDA will approve Advanced Bionics new software " ClearVoice " that has

been available worldwide except for the USA for over a year. Can't wait to get

this new software!!

>

> Update: FDA Approval for Return to Market in United States

>

> ****Update: FDA Approval for Return to Market in United States****

>

> Advanced Bionics HiRes 90K Cochlear Implant September 13, 2011

>

>

> Advanced Bionics is pleased to announce that we have received approval from

> the FDA to resume distribution of the HiRes 90KTM implant in the United

> States. Please note that our ability to provide implants to cochlear implant

> centers will vary due to limited supply in the initial weeks of AB's

> re-entry to the US market. Your local Advanced Bionics representative will

> keep you informed as we prepare to resume the distribution of HiRes 90K

> implants to your centers.

>

>

> Finally, we would like to provide you with an update on the status of AB's

> voluntary HiRes 90K implant recall. Our investigation continues to show that

> of the more than 28,000 implanted HiRes 90K devices, only two (0.007%)

> explanted devices have been confirmed to have the issue. You can trust that

> AB will stand by our commitment to putting patients first.

>

>

> We would like to thank you for your patience, understanding, and support

> while we resolved the HiRes 90K implant recall and return to markets across

> the globe. AB remains firmly committed to making a difference in the lives

> of those impacted by hearing loss and we look forward to continuing this

> important mission in partnership with you.

>

>

> Sincerely,

> Gerhard Roehrlein, PhD

>

> CEO and CTO Advanced Bionics, LLC

>

> ………………

>

> From: bhNEWS [mailto:bhNEWS ] On Behalf Of

> MacPherson

> Sent: Tuesday, September 13, 2011 11:39 AM

> bhNEWS

> Subject: [bhNEWS] FDA Green Flags Advanced Bionics Implant for Return to

> Market

>

>

>

>

>

> Press release, Sonova - September 13, 2011

>

> ---------------

>

> Sonova announces FDA approval for U.S. market re-entry of the Advanced

> Bionics HiRes 90K cochlear implant

>

> Stäfa (Switzerland), 13.09.2011 – Sonova is pleased to announce the

> immediate market re-entry of the Advanced Bionics HiRes 90K cochlear implant

> in the United States. In recent months, Advanced Bionics (AB) received

> approval from several other regulatory bodies, including Health Canada and

> the European Notified Body (TÜV), to resume distribution of the HiRes 90K

> cochlear implant to Canada and countries accepting the CE Mark. With the

> approval of the Food and Drug Administration (FDA), Advanced Bionics can

> resume distribution in the United States and re-enter all markets worldwide.

>

> .............

>

> Complete release:

> http://www.sonova.com/en/investors/news/Pages/fdaapproval20110913.aspx

>

>

>

>

>

>

>

>

[Guest guest]

Me too! I'm sure it will be available sometimes early next year.

I'm having simultaneous bilateral surgery next Friday. I might even be one of

the first implantees in the US since the recall was lifted.

And also look out for the world's first true waterproof processor coming out

from AB in January or Feburary.

> >

> > Update: FDA Approval for Return to Market in United States

> >

> > ****Update: FDA Approval for Return to Market in United States****

> >

> > Advanced Bionics HiRes 90K Cochlear Implant September 13, 2011

> >

> >

> > Advanced Bionics is pleased to announce that we have received approval from

> > the FDA to resume distribution of the HiRes 90KTM implant in the United

> > States. Please note that our ability to provide implants to cochlear implant

> > centers will vary due to limited supply in the initial weeks of AB's

> > re-entry to the US market. Your local Advanced Bionics representative will

> > keep you informed as we prepare to resume the distribution of HiRes 90K

> > implants to your centers.

> >

> >

> > Finally, we would like to provide you with an update on the status of AB's

> > voluntary HiRes 90K implant recall. Our investigation continues to show that

> > of the more than 28,000 implanted HiRes 90K devices, only two (0.007%)

> > explanted devices have been confirmed to have the issue. You can trust that

> > AB will stand by our commitment to putting patients first.

> >

> >

> > We would like to thank you for your patience, understanding, and support

> > while we resolved the HiRes 90K implant recall and return to markets across

> > the globe. AB remains firmly committed to making a difference in the lives

> > of those impacted by hearing loss and we look forward to continuing this

> > important mission in partnership with you.

> >

> >

> > Sincerely,

> > Gerhard Roehrlein, PhD

> >

> > CEO and CTO Advanced Bionics, LLC

> >

> > ………………

> >

> > From: bhNEWS [mailto:bhNEWS ] On Behalf Of

> > MacPherson

> > Sent: Tuesday, September 13, 2011 11:39 AM

> > bhNEWS

> > Subject: [bhNEWS] FDA Green Flags Advanced Bionics Implant for Return to

> > Market

> >

> >

> >

> >

> >

> > Press release, Sonova - September 13, 2011

> >

> > ---------------

> >

> > Sonova announces FDA approval for U.S. market re-entry of the Advanced

> > Bionics HiRes 90K cochlear implant

> >

> > Stäfa (Switzerland), 13.09.2011 – Sonova is pleased to announce the

> > immediate market re-entry of the Advanced Bionics HiRes 90K cochlear implant

> > in the United States. In recent months, Advanced Bionics (AB) received

> > approval from several other regulatory bodies, including Health Canada and

> > the European Notified Body (TÜV), to resume distribution of the HiRes 90K

> > cochlear implant to Canada and countries accepting the CE Mark. With the

> > approval of the Food and Drug Administration (FDA), Advanced Bionics can

> > resume distribution in the United States and re-enter all markets worldwide.

> >

> > .............

> >

> > Complete release:

> > http://www.sonova.com/en/investors/news/Pages/fdaapproval20110913.aspx

> >

> >

> >

> >

> >

> >

> >

> >