Author Topic: GOOD NEWS...NEW INVENTION FOR SSD... Sounds good for us!!!!  (Read 196553 times)

Arasha

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Re: GOOD NEWS...NEW INVENTION FOR SSD... Sounds good for us!!!!
« Reply #75 on: January 01, 2010, 09:44:48 pm »
Jan,

Thanks for the info, I'll pass it on.

Gloria
Left side AN 2.5x1.8 removed on 10/17/2007 endosc. by Dr.Shahinian (retrosig) at SBI, LA,Ca. Facial phalsys (almost back). Balance issues. Tinnitus. MRI 8 months later showed AN was resected completelly.TransEar 11/2008. Clinical trial for SoundBite 11/2009. SoundBite user.I have the best family.

Arasha

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Re: GOOD NEWS...NEW INVENTION FOR SSD... Sounds good for us!!!!
« Reply #76 on: January 12, 2010, 11:08:50 am »
Hi everyone,

I will be returning my SoundBite on January the 23rd; my 60 day clinical trial will be coming to an end. Kinda sad .

My experiences during this time with the SoundBite are as follows;

IN QUIET CONDITIONS:

-   I have noticed that speech recognition is almost perfect on both sides in quiet environments. I originally thought I didn’t need a hearing aid in these kinds of environments but after trying the SoundBite I noticed a difference, the voices and sounds are much clearer.
-   Definitely helps with the directionality.
-   I can hear even the quietest sounds, for example, when someone is whispering on my deaf side.
-   While I am watching TV and someone is talking to me on my good side I can still hear the TV, which was a problem without the device.
-   If I am chewing while watching TV (i.e. crackers or something crunchy) I can still hear the program, without the device I would sometimes have to stop chewing in order keep from missing something. It would seem that the SoundBite filters the sound of chewing.
-   If I fall sleep over my AN side (while wearing the SoundBite) I don’t have feedback.
-   I can wear a helmet and ride the motorcycle without any problems. I don’t get any feedback or discomfort.
-   I can wear hats or beanies without any complication.
-   When my husband is seated next to me, he likes to caress (by rubbing) my shoulder. Without the device, if he rubs my shoulder on my good side the sound would sometimes annoy me to the point where I would have to stop his hand. When I wear the SoundBite it does not bother me, I guess because I have hearing on both sides and my brain doesn’t concentrate on only the sounds from my good side.
-   It is more pleasant to attend a lecture, everything is clearer.
-   I can hear the noise of my rubbing fingers in my deaf side.
-   If I lay down over my good side while wearing the device I can still hear.
-   I can speak on the cell phone using my bad ear but sometimes I experience feedback.
-   I don’t have feedback when someone gives me a big hug.





IN NOISY ENVIRONMENTS:

-   It is very helpful in the theatres; I can usually hear, on my deaf side, when someone is whispering in the next row. I can also hear my husband commenting about the movie when he ends up seated on my deaf side.
-   It helps in restaurants, I am able to hear what the waitress is saying and I am able to hear the person seated on my deaf side.
-   While attending a concert (Metallica :-O ), I had problems holding a conversation while they were playing (I had an ear plug in my good ear) but my husband said that even for him it was next to impossible.
-   At the supermarkets or grocery stores, as I have mentioned before, I consider my hearing to be about 55% of what it would otherwise be on the deaf side when wearing the SoundBite. I don’t know why but it seems that the sounds in supermarkets and grocery stores are just weird that way.
-   Walking on streets with traffic and talking with someone on my deaf side is not a problem.
-   When washing dishes while wearing the SoundBite, the sound of the running water from the faucet is less distracting, especially while holding a conversation with someone.
-   I have noticed that the sounds of the ambulances or police cars are not as annoying while wearing the device, without it those sounds drive me crazy.
-   The other day I heard a noise while driving my car which I could not hear when I took out the device. When I asked my husband to check the car he was surprised that I could hear the noise at all. It turns out the noise was not that loud and was coming from the tire in the back.

GENERAL COMMENTS:

To wear the SoundBite is simple; the ITM (In The Mouth) is easy to wear and does not affect your speech or eating. It is not visible when you are smiling.

The BTE (Behind The Ear) is almost unnoticeable, the sound tube is transparent and thin and the part which goes behind the ear is small.

The doctors at Sonitus told me that the final device will be improved in both design and functionality. As I have posted before, in my 30 day follow up appointment I received a new ITM (I think it is part of the study plan). The new ITM battery has been lasting a minimum of 5 hours and I am told that by the time the final device is ready for market it is expected to get up to around 7 hours.

Cleaning is easy, just rinse the ITM with water or clean with dental cleansing wipes (the ones used for retainers). The BTE is just cleaned as needed with a Q-tip.

I am very pleased to have been part of this trial and to have been given a chance to try out such a promising device. This device continues to give hope to a huge group of us with SSD who are waiting for something non-invasive. I am glad that the doctors are working on improving the lives of people like us with SSD.

SOUNDBITE IS SIMPLY AWESOME!

Thank you everyone for your comments, personal messages and encouragement. I will let you know if I have anything more to share.

For sure everyone is now waiting to hear from Carolyn (she will start the trial this month on the 18th), I know I am. Please share with us your experience Carolyn.

Best wishes to everyone,
Gloria

PS. I wanted to enclose a picture wearing the BTE but I don't know how.
Left side AN 2.5x1.8 removed on 10/17/2007 endosc. by Dr.Shahinian (retrosig) at SBI, LA,Ca. Facial phalsys (almost back). Balance issues. Tinnitus. MRI 8 months later showed AN was resected completelly.TransEar 11/2008. Clinical trial for SoundBite 11/2009. SoundBite user.I have the best family.

saralynn143

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Re: GOOD NEWS...NEW INVENTION FOR SSD... Sounds good for us!!!!
« Reply #77 on: January 12, 2010, 11:17:38 am »
Thank you so much for the thorough review, Gloria. I am part of another group for hemifacial spasm where I can share information such as this.

I am so sad you have to give it up! If I ran Soundbite (and since I don't, I can afford to be generous), I'd let you keep it.

Sara
MVD for hemifacial spasm 6/2/08
left side facial paresis
 12/100 facial function - 7/29/08
 46 - 11/25/08
 53 - 05/12/09
left side SSD approx. 4 weeks
 low-frequency hearing loss; 85% speech recognition 7/28/08
1.8 gram thin profile platinum eyelid weight 8/12/08
Fitted for scleral lens 5/9/13

JerseyGirl2

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Re: GOOD NEWS...NEW INVENTION FOR SSD... Sounds good for us!!!!
« Reply #78 on: January 12, 2010, 11:32:26 am »
Gloria,

What an excellent report you've written -- thank you! It sounds as though the SoundBite is a really useful device -- certainly in your case, at least -- and will hopefully prove to be yet another alternative for SSD folks to explore.

I hope that they will start producing them for sale before too long and that you'll be the first one in line to receive one!

Catherine (JerseyGirl 2)
Translab surgery and BAHA implant: House Ear Institute, Los Angeles, 1/2008
Drs. J. House, Schwartz, Wilkinson, and Stefan
BAHA Intenso, 6/2008
no facial, balance, or vision problems either before or after surgery ... just hearing loss
Monmouth County, NJ

GRACE1

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Re: GOOD NEWS...NEW INVENTION FOR SSD... Sounds good for us!!!!
« Reply #79 on: January 12, 2010, 11:39:38 am »
Gloria,

Thank you so much for the informative post.  It addressed a lot of my issues.  This device sounds great!

Grace
Diagnosed 7/06: AN - right side: 1.3cm in transverse dimension, 6mm in AP dimension, and 6mm in cephalocaudal dimension.
GK 12/06- Wake Forest Univ Baptist Med Ctr
MRI 5/07- Some necrosis;  Now SSD
MRI 12/08- AN size has reduced 50%
MRI 12/11- AN stable (unchanged from 12/08)
Next MRI: 12/16

raj_06

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Re: GOOD NEWS...NEW INVENTION FOR SSD... Sounds good for us!!!!
« Reply #80 on: January 13, 2010, 11:09:54 am »
Hi Gloria,
9(
Thank you so much for trying Soundbite and letting us know about your experience with it. I am definitely in line to get one of those (or at least try) . Do you know when will they start selling it in the market? And, how much the price would be?

Regards,
Raj
"After all these ordeals, I still say all is well":)

Larry

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Re: GOOD NEWS...NEW INVENTION FOR SSD... Sounds good for us!!!!
« Reply #81 on: January 13, 2010, 03:53:25 pm »
Gloria,

Great report and I will certainly be waiting for it to reach my shores down under.

Laz
2.0cm AN removed Nov 2002.
Dr Chang St Vincents, Sydney
Australia. Regrowth discovered
Nov 2005. Watch and wait until 2010 when I had radiotherapy. 20% shrinkage and no change since - You beauty
Chronologer of the PBW
http://www.frappr.com/laz

Arasha

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Re: GOOD NEWS...NEW INVENTION FOR SSD... Sounds good for us!!!!
« Reply #82 on: January 13, 2010, 11:26:58 pm »
Hi everyone,

Here is the picture of me wearing the SoundBite BTE (Behind The Ear) trial device. As you can see it is hardly noticeable.

Gloria

Left side AN 2.5x1.8 removed on 10/17/2007 endosc. by Dr.Shahinian (retrosig) at SBI, LA,Ca. Facial phalsys (almost back). Balance issues. Tinnitus. MRI 8 months later showed AN was resected completelly.TransEar 11/2008. Clinical trial for SoundBite 11/2009. SoundBite user.I have the best family.

Arasha

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Re: GOOD NEWS...NEW INVENTION FOR SSD... Sounds good for us!!!!
« Reply #83 on: January 13, 2010, 11:55:29 pm »

Hi Raj;

Thanks for your comment. According to Sonitus Medical (the inventors) it could be available as early as mid/2010.

Regarding the price, Grace got the information from Sonitus: "it will likely be in the $4,000 ballpark". As I said before, they are working hard to get the coverage from the insurances because it will not be considered as a hearing aid.

Here I send you the link of their website, you can contact them for more specific details.
http://www.sonitusmedical.com/

Take care,
Gloria




Left side AN 2.5x1.8 removed on 10/17/2007 endosc. by Dr.Shahinian (retrosig) at SBI, LA,Ca. Facial phalsys (almost back). Balance issues. Tinnitus. MRI 8 months later showed AN was resected completelly.TransEar 11/2008. Clinical trial for SoundBite 11/2009. SoundBite user.I have the best family.

Arasha

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Re: GOOD NEWS...NEW INVENTION FOR SSD... Sounds good for us!!!!
« Reply #84 on: January 14, 2010, 12:00:08 am »


Thanks Sara, Catherine (JerseyGirl 2), Grace, Laz  for all your comments.

Have a great day,
Gloria
Left side AN 2.5x1.8 removed on 10/17/2007 endosc. by Dr.Shahinian (retrosig) at SBI, LA,Ca. Facial phalsys (almost back). Balance issues. Tinnitus. MRI 8 months later showed AN was resected completelly.TransEar 11/2008. Clinical trial for SoundBite 11/2009. SoundBite user.I have the best family.

leapyrtwins

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Re: GOOD NEWS...NEW INVENTION FOR SSD... Sounds good for us!!!!
« Reply #85 on: January 14, 2010, 07:32:01 am »
Gloria -

I'm a little confused here (yes, again, Pooter) and you've probably said this in a prior post, but how is the Sound Bite not considered a hearing aid?

I know it works through bone conduction, but it's not an implant or a prothesis like the BAHA - and the only thing that makes it different from a conventional hearing aid is the piece in the mouth.  What "grounds" does Sonitus have to make their case?

Thanks,

Jan
« Last Edit: January 14, 2010, 07:33:32 am by leapyrtwins »
Retrosig 5/31/07 Drs. Battista & Kazan (Hinsdale, Illinois)
Left AN 3.0 cm (1.5 cm @ diagnosis 6 wks prior) SSD. BAHA implant 3/4/08 (Dr. Battista) Divino 6/4/08  BP100 4/2010 BAHA 5 8/2015

I don't actually "make" trouble..just kind of attract it, fine tune it, and apply it in new and exciting ways

Pooter

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Re: GOOD NEWS...NEW INVENTION FOR SSD... Sounds good for us!!!!
« Reply #86 on: January 14, 2010, 11:45:48 am »
Jan,

Heh.. I detect a pattern here..  Be that as it may, I was wondering the same thing.  Certainly, I can see Cochlear's "case" for calling the BAHA an implant, but it's more gray to call the SoundBite anything other than a hearing aid.  Perhaps their trying to follow some lines of it being like some detal prosthetic, however I'd wager the insurance companies will say that dental insurers should cover it if that's the case...

I wonder how they'll get over that hurdle..

Thanks, Gloria, for the comments and the picture.  I remain unimpressed (although to a lesser degree) with the battery life.  They've got to find a way to make it last longer than a "typical" person's waking hours to even begin to make it useful for someone like me.  I know they're working on that, but for them to even say that their "goal" is to get it up to 7 hours is problematic.  Most people work longer than that..  In addition to working hours, they have "awake" time both before and after work where, presumably, they'd want the benefits of the SoundBite.  Personally, I think if Cochlear can make their battery last for days, and the makers of TransEar can make theirs last for days, and Orticon can make their Ponto pro last for days.. I don't think it's out of the realm of possibility for them to make their battery last longer than 7 hours.

I like the concept of the SoundBite (even though the in the mouth part seems a bit weird).. I think with some dramatic improvements in the battery life, they may just have a viable alternative for those with SSD especially those that don't want surgery or the predicament of getting a snugly fit ITE (TransEar).

Regards,
Brian
Diagnosed 4/10/08 - 3cm Right AN
12hr retrosig 5/8/08 w/Drs Vrabec and Trask in Houston, Tx
Some facial paralysis post-op but most movement is back, some tinitus.  SSD on right.
Story documented here:  http://briansbrainbooger.blogspot.com/

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raj_06

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Re: GOOD NEWS...NEW INVENTION FOR SSD... Sounds good for us!!!!
« Reply #87 on: January 14, 2010, 09:19:57 pm »
Hi Gloria,
 Thanks for the information and the link. This device really seems is great. I wish the price were lower than that. Probably it's worth it anyways. I am looking forward to trying it later this year.

Regards,
Raj
"After all these ordeals, I still say all is well":)

Arasha

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Re: GOOD NEWS...NEW INVENTION FOR SSD... Sounds good for us!!!!
« Reply #88 on: January 15, 2010, 12:27:11 am »
Gloria -

I'm a little confused here (yes, again, Pooter) and you've probably said this in a prior post, but how is the Sound Bite not considered a hearing aid?

I know it works through bone conduction, but it's not an implant or a prothesis like the BAHA - and the only thing that makes it different from a conventional hearing aid is the piece in the mouth.  What "grounds" does Sonitus have to make their case?

Thanks,

Jan

Jan,

Thank you for your excellent question, I was wondering the same thing myself. I sent an email to Sonitus to see if they could provide us the answer. I received a response from Jason Shelton of Sonitus and I have included it below.

Here is his reply:

####################

Hi Gloria,
There are two perspectives from which reimbursement coverage for new medical devices can be sought: 1) on the basis of the nature of technology itself and 2) on the basis of the patient who is being treated with that technology. Initially, coverage for new devices is often sought on the basis of the later, which if successful leads to policies providing coverage that describe the former. It is incumbent on the manufacturer to invest time and resources to build the case to get reimbursement for their product up front on the basis of one, the other, or both perspecives. And it's a big process. Perhaps the makers of TransEar never sought reimbursement coverage for their device for one reason or another and as a result the device wound up being classified as a hearing aid, I don't know. Nonetheless this is exactly what Sonitus intends to do.
 
Now when breakthrough technologies like SoundBite come along, they are sometimes tough to classify strictly on the nature of the technology itself. Hearing aids, for example, are generally not reimbursed and legislation was created specifically to exclude them. However the SoundBite hearing system is not a hearing aid, insofar as it does not amplify sound or for that matter even use the air conduction pathway to transmit sound as hearing aids do. Today however, Single Sided Deafness (SSD) is a disease whose treatment is currently covered by insurance. On that basis alone we could argue that our device should be covered. But in fact, the standard reimbursed treatment for SSD is surgical in nature, with a total cost to the payer of $12K-$15K and sometimes more. Now it's true that our new device is not surgical, but that is actually a plus because the total cost of care that an insurance company would have to pay for a patient's treatment with our device will be significantly less that with an invasive implant surgery. Medical innovations that decrease medical costs like SoundBite are looked upon favorably, especially in the currently changing US healthcare system.

Sonitus is going to fight for reimbursement starting from the perspective of the patient. We will seek reimbursement for our device on the basis that, if a patient is a candidate for a currently reimbursable surgery for an implant to treat their condition (SSD), they would be no less effectively treated for that condition by receiving our device at a total cost to the payer (insurance company) that is significantly less.

I hope that helps clarify things,
 
Jason Shelton
VP Marketing, Sonitus Medical


####################

I think that helps to clear things up at least it does for me. It seems reasonable , I hope everything goes according to plan.

Cheers,
Gloria
« Last Edit: January 15, 2010, 12:35:05 am by Arasha »
Left side AN 2.5x1.8 removed on 10/17/2007 endosc. by Dr.Shahinian (retrosig) at SBI, LA,Ca. Facial phalsys (almost back). Balance issues. Tinnitus. MRI 8 months later showed AN was resected completelly.TransEar 11/2008. Clinical trial for SoundBite 11/2009. SoundBite user.I have the best family.

Arasha

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Re: GOOD NEWS...NEW INVENTION FOR SSD... Sounds good for us!!!!
« Reply #89 on: January 15, 2010, 12:53:30 am »

I remain unimpressed (although to a lesser degree) with the battery life. 

Regards,
Brian

Hi Brian,

I agree, for sure they need to continue to address the battery life if they wish to appeal to the broadest group of patients. Changing and charging throughout the day is a workaround at best and is probably manageable for most, albeit a nuisance, it certainly is not realistic for everyone.

Have a good day,
Gloria
Left side AN 2.5x1.8 removed on 10/17/2007 endosc. by Dr.Shahinian (retrosig) at SBI, LA,Ca. Facial phalsys (almost back). Balance issues. Tinnitus. MRI 8 months later showed AN was resected completelly.TransEar 11/2008. Clinical trial for SoundBite 11/2009. SoundBite user.I have the best family.

 


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