Re: AB Technology Update: Harmony the Sound of the Future

[Guest guest]

Houston, we have a problem! <G> I just discovered that the URL for the

" slide-set " from the course was not available for other than course

participants.

No big deal. I will happily send the pdf file to any upon request!

Bob

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

AB Technology Update: Harmony the Sound of the Future

Hi all! I had the pleasure of attending an online class today presented by

Advanced Bionics, hosted by Audiology Online. The course title:

Advanced Bionics Technology Update: Harmony the Sound of the Future

Presenting was Trautwein, Au.D, Manager of Professional Education

and Training at Advanced Bionics Corporation

Dr Trautwein began with a brief overview of the cochlear implant and the

criteria for candidacy and moved on to the explanation of currant steering

in the HiRes90K and the new HiRes 120 processor software, and the benefits

derived therefrom. We got to see the new Harmony, which is an upgrade of the

Auria, and learned about it's new features including a built in T-coil and

greatly extended battery life with the power-miserly new software.

Answering a question from the class, Dr. Trautwein stated that the

commercial release of the HiRes120 software and the Harmony processor, both

in final stages of clinical trials, is expected after the first of next

year.

Dr. Trautwein briefly addressed the issue of backward compatibility for

the Harmony, which will include the CII and HiRes90K implants.

But, I foresaw other related queries and asked Sandy Mintz, M.S.,CCC-A

of AB for clarification and embellishment on compatibilty of earlier

implants with the HIRes120 software. Here is her reply as edited for

clarity:

" AB remains committed to making the Harmony BTE compatible with earlier

(i.e, C1) internal implants. HiRes 120 will not be compatible with those

earlier implants due to fundamental implant design differences.

Nevertheless, AB is investigating the applicability and potential benefits

of new processing strategies for these individuals. "

For those of interest further, I believe you will Enjoy and Learn from the

" slide-set " upon which Dr. Trautwein's presentation was based,

All of the course participants were given a virtual " handout " , the

slides, and I would like to share them with you now:

http://www.audiologyonline.com/management/uploads/classes/6322_AO_AB_TW_08

3006.pdf

Bob

[Guest guest]

I would like a PDF of the slides.

Thank you.

Jan

[Guest guest]

Jan,

The URL for the slide set is in the post. If its broken, just copy and

paste the link into your browser.

*---* *---* *---* *---* *---*

If Barbie is so popular, why do you have to buy her friends?

--

& Dreamer Doll (Guide Dawggie)

Newport, Oregon

N24C 3G 8/2000 Hookup

rclark0276@...

http://webpages.charter.net/dog_guide/

[Guest guest]

The PDF file downloaded OK from that URL, for me, Bob. Its a nice

looking advertising brochure from AB. Good luck to the ones that

stand to benefit from its technology. I'm all for progress, no matter

where it comes from.

Ted F.

>

> All of the course participants were given a virtual " handout " , the

> slides, and I would like to share them with you now:

>

>

http://www.audiologyonline.com/management/uploads/classes/6322_AO_AB_T

W_083006.pdf

>

> Bob

>

[Guest guest]

Hi all! The URL for the " slide show " is up and flying again!

Here's a TinyUrl to foil those nasty line-breaks and truncated links on

lists:

http://tinyurl.com/pcmgw

Bob

[Guest guest]

I noticed a line on a slide (on slide 4 of page 4 of the pdf document)

that states:

Optional feature for adults only.

Any idea when the HiRes120 will be made available for children?

Thanks.

[Guest guest]

Dear Sushilb: Based on the latest information available, the HiRes Fidelity

120 software has already been approved in Europe and Canada, and the delay

in US approval lies in the muddled bureaucracy of our FDA. Nothing new here.

With the expected commercial roll-out date for the Harmony and the 120

software for adults pegged as after the first of the year or before, then

parents can only pray that the FDA gets their act together before then, thus

allowing AB to announce full approval of the Harmony and the Hi Res

Fidelity 120 software in one fell swoop!

That would be cool!

It WILL happen! Give the AB CI centers time to get the official word before

bugging them. And one thing I can promise:

When full approval, adult or children's, of the Hi Res Fidelity 120 is

obtained, everyone in CI land will know about it.

Bob

...........

> Re: AB Technology Update: Harmony the Sound of the

> Future

>

>

> I noticed a line on a slide (on slide 4 of page 4 of the pdf document)

> that states:

> Optional feature for adults only.

>

> Any idea when the HiRes120 will be made available for children?

>

> Thanks.

>

>

>

>

>

>

>

[Guest guest]

Bob, you do a great job of keeping everyone informed, so we'll look

forward to hearing it from you first.

In the mean time though, parents might recall that no device is

approved by the FDA for patients under 12mos of age (used to be 18mo

and before that 2yrs), yet children are often implanted even younger

because the doc knows it'll benefit them.

The FDA merely approves what a company can 'market' (sell), and how

they can label it's recommended usage, but they don't regulate how

professional clinicians prescribe devices for an individual patient.

Surgeons implant younger children because they are convinced it will

benefit the child to do so.

In the same fashion, a clinician could map a child with a strategy

approved only to market for adults if they felt the child would

benefit from it.

We're only talking software here, which is much less risky to try

than surgery.

The FDA is not setup to distinguish the differences, and so they

apply a rather broad standard, and every CI development has

generally been approved first for adults, then children.

Manufacturers have to abide by their rules or they'd be breaking the

law, but regardless of that, it's the doc or audie who decides

whether it can be used for a given patient.

I know I'll be bugging my daughter's audie before full FDA blessing

is given for children - although if you're right about the timing, I

won't have to. Either way, it's an exciting couple of months ahead

of us. Windows Vista and HR120 both on the near term horizon, and

don't forget the Freedom BTEs for N24 patients, as well as Leopard a

few months later for you Mac folks.

Seems as though everyone is getting something new soon.

Steve

>

> Dear Sushilb: Based on the latest information available, the

HiRes Fidelity

> 120 software has already been approved in Europe and Canada, and

the delay

> in US approval lies in the muddled bureaucracy of our FDA. Nothing

new here.

>

> With the expected commercial roll-out date for the Harmony and

the 120

> software for adults pegged as after the first of the year or

before, then

> parents can only pray that the FDA gets their act together before

then, thus

> allowing AB to announce full approval of the Harmony and the Hi

Res

> Fidelity 120 software in one fell swoop!

>

> That would be cool!

>

> It WILL happen! Give the AB CI centers time to get the official

word before

> bugging them. And one thing I can promise:

>

> When full approval, adult or children's, of the Hi Res Fidelity

120 is

> obtained, everyone in CI land will know about it.

>

> Bob

> ..........

>

>

> > Re: AB Technology Update: Harmony the Sound of

the

> > Future

> >

> >

> > I noticed a line on a slide (on slide 4 of page 4 of the pdf

document)

> > that states:

> > Optional feature for adults only.

> >

> > Any idea when the HiRes120 will be made available for children?

> >

> > Thanks.

> >

> >

> >

> >

> >

> >

> >