HearPeers Heroes Adam Posted May 28, 2015 HearPeers Heroes Report Share Posted May 28, 2015 Any guesses when the FDA will finish the approvals for the Sonnet? I haven't heard much. Usually at least hear of a timeframe which is somewhat accurate. This time nothing yet. Adam Quote Link to comment Share on other sites More sharing options...
HearPeers Heroes Ivana Marinac Posted May 28, 2015 HearPeers Heroes Report Share Posted May 28, 2015 Adam - what am I missing? Link: http://s3.medel.com/pdf/US/24967_r10_SONNET_FDA%20Approval-Press-Release.pdf FDA already approved Sonnet. Quote Link to comment Share on other sites More sharing options...
HearPeers Heroes Ivana Marinac Posted May 28, 2015 HearPeers Heroes Report Share Posted May 28, 2015 First patient in the USA: http://s3.medel.com/pdf/US/SYNCHRONY_First_Surgery_3.24.15.pdf Quote Link to comment Share on other sites More sharing options...
HearPeers Heroes Adam Posted May 28, 2015 Author HearPeers Heroes Report Share Posted May 28, 2015 Ivana, that is for the implant. The processor (sonnet) had to get approval as well, which it did. There are certain features to the sonnet that are still awaiting approval. One of which is the second microphone. People are recieving them but the are essentially opus 2s Quote Link to comment Share on other sites More sharing options...
HearPeers Heroes Adam Posted May 28, 2015 Author HearPeers Heroes Report Share Posted May 28, 2015 The sonnet has two microphones. The opus has one. I believe but Am not 100%, that the water wear for the sonnet has not been approved by the FDA either. At least yet Quote Link to comment Share on other sites More sharing options...
HearPeers Heroes Ivana Marinac Posted May 29, 2015 HearPeers Heroes Report Share Posted May 29, 2015 Pardon me - I didn't understand these peculiarities... It would never cross my mind that FDA approves parts of the device.... Quote Link to comment Share on other sites More sharing options...
HearPeers Heroes Adam Posted May 29, 2015 Author HearPeers Heroes Report Share Posted May 29, 2015 I didn't know that either, Ivana. Somebody had to tell me Quote Link to comment Share on other sites More sharing options...
djr41180 Posted June 1, 2015 Report Share Posted June 1, 2015 I'm wondering if anyone knows when FDA approval is expected for (a) the rechargeable battery pack for the Sonnet, or ( the hearing aid component built into the Sonnet. My daughter just got her second implant in April, and the surgeons did a "soft insertion" to try to preserve any lower frequency hearing she has. The goal was to have her use both a hearing aid and the CI on that ear to allow her the most access to sound. But right now she has to wear her Rondo with a behind the ear hearing aid, and we are trying to get Med El to tell us when we can expect FDA approval of the built in hearing aid because this set up is extremely cumbersome (she's 4). They say they can't give us any dates. Yet, I just saw that Cochlear just got their combo CI/hearing aid device approved by the FDA. ??? What can we do to get Med El moving on this as well? Anyone have any thoughts, advice or info? Quote Link to comment Share on other sites More sharing options...
HearPeers Heroes Adam Posted June 1, 2015 Author HearPeers Heroes Report Share Posted June 1, 2015 Djr41180 First let me welcome you to hearpeers!! In answer to your question, MED-EL or any other cochlear implant company have no control whatsoever in how fast the FDA approves anything they submit. The reason they could not give you a date is because the FDA does not tell them when things will be approved. Mostly what you will see are guesses. I have heard a rumor that the rechargeable batteries for the sonnet might be approved sometime in the summer of 2016. Sadly we are at the mercy of the FDA. There is nothing MEDEL can do to speed things up. Some things take longer than others as the FDA might request more info on a particular segment of what has been submitted. It can be frustrating hearing about our friends in Europe who usually get all the new technology first. The only thing you can do is try to be patient. Probably not theist you wanted to read. Also, what "hearing aid component" are you referring to? Please let us know how she is doing. Quote Link to comment Share on other sites More sharing options...
djr41180 Posted June 2, 2015 Report Share Posted June 2, 2015 Thanks for the welcome and the response! With respect to the hearing aid component, our audiologist inform us that the Sonnet has the ability to be used as a hybrid CI/Hearing aid device. To use the hearing aid device, we need to change out the ear hook, put on an earmold with tubing, and activate the hearing aid. But the hearing aid aspect cannot be "turned on" yet. I know that the complete system is approved in Europe, for adults, but when we asked Med El if any clinical trials were being conducted in the US (to see if our daughter could participate), they said no. So I'm not sure if that means the trials are done and everything is with the FDA waiting for their review and approval or if no trials have even been conducted yet? I'm just wondering where things stand. And I can't seem to get any clear answers from Med El. I guess I'm most frustrated because I learned just today that the very similar technology developed by Cochlear has already received FDA approval. And the rechargeable batteries may not be approved until 2016?? Oh my. Quote Link to comment Share on other sites More sharing options...
HearPeers Heroes Adam Posted June 2, 2015 Author HearPeers Heroes Report Share Posted June 2, 2015 i feel for you! I know it can be very frustrating, especially when not getting a straight answer. I can tell you this, hopefully it will bring some peace of mind. I knew a great deal about cochlear implants years before it looked like I would need one. I am 47 years old and started losing my hearing in my early 20's. I did EXTENSIVE research into all 3 companies and MED-EL was a no brainer, for a number of reasons. I have seen and held the rondo but didn't think it would fit my lifestyle. I am very active in martial arts and ultra marathons. The good news is, your little one is now getting some sound stimulus from both ears (correct me if I am wrong) that is huge in her development on a number of different levels. Even if it is one ear, that will help more than you know. I guess it is a blessing in a way that the big issue is keeping the rondo on her head. MEDEL does make a sports headband for the rondo to help hold it into place. That might help a little. I know you are probably way more frustrated than I realize. I believe, especially with her age, you have chosen the right company. Sadly, all of us have to hold our breath and wait for the FDA. I am in the process of trying to upgrade to the sonnet. Feel free to ask any questions that you might have about my hearing journey, or anything else for that matter. Adam Quote Link to comment Share on other sites More sharing options...
HearPeers Heroes Adam Posted June 2, 2015 Author HearPeers Heroes Report Share Posted June 2, 2015 Forgot to mention, I have bilateral (2) implants four years this month. Quote Link to comment Share on other sites More sharing options...
HearPeers Heroes hadron Posted June 3, 2015 HearPeers Heroes Report Share Posted June 3, 2015 Yes the SONNET processor has been approved by the FDA but as Adam and djr41180 have noted some key pieces are still missing. 1. The Hybrid device djr41180 speaks of is the SONNET EAS processor. If you look at the FDA Approval press release, SONNET EAS processor is not mentioned. When you were told the hearing aid aspect cannot be "turned on" yet, MED-EL means that the the hearing aid component is built into the SONNET EAS Processor but the software for EAS is not currently available. Once the software is available your CI center will receive it and can then turn on the hearing aid aspect. Hybrid (Electric-Acoustic) processing in children is expected to be a big growth area for CIs so I expect the SONNET EAS software to be available soon. If your child is a music talent some early research has shown dramatic performance differences between Hybrid and traditional implants as noted below: https://www.researchgate.net/post/What_are_the_most_recent_advances_regarding_cochlear_implantation_CI_devices/1 2. The second microphone is currently a part of the SONNET processor but like SONNET EAS it cannot be "turned on yet". Once the second microphone software is available your CI center will receive it and can then turn on the second microphone. With the second microphone the SONNET has two omni microphones which allow it to directionally focus on sounds. Since this is a crucial part of Automatic Sound Management (AMS) 2.0, I expect that it will be available soon. 3. The rechargeable battery is not available for the SONNET processor. This may take a while if it is has to be FDA approved. 4.The WaterWear is not available for the SONNET processor. This may take a while if it is has to be FDA approved. 5. So how did the SONNET processor get FDA approval with key pieces of software missing? Since all the hardware is available along with the coding strategy software, it was probably good enough to get FDA approval. 6. Is it worth purchasing the SONNET with the above stuff missing? Am I just getting another OPUS 2? Ironically I am currently trying to make this decision. I have been approved for an upgrade from the OPUS 2 procesor to the SONNET. I believe the SONNET offers you a significant upgrade to the OPUS 2 with its many new features (2.4GHz Wireless interface, ASM 2.0, 2 omni directional microphones, WNR, automatic volume control, IP54 water/dust rating, new more durable transmitting cables, modular CI design, data logging). Hopefully these new features will remove many of the problems that occur with the OPUS 2 processor system. The wireless interface is really exciting to me but unfortunately MED-EL does not yet have wireless accessories unlike Cochlear (Phone Clip, Mini mic, TV streamer). The first wireless accessory will probably be the Quattror Blue Tooth Neck Loop. The OPUS 2 Automatic Sound Management (ASM) 1.0 really doesn't do anything. If I don't adjust my CI with the Fine Tuner, a bad listening situation never changes. Hopefully with the two microphones, WNR and automatic volume control, ASM 2.0 will actually happen. The microphones are badly needed because without directional processing noise just comes from everywhere. The new transmitting cable which connects to the D-Coil is probably the most needed improvement, in 5 years I have probably used more than 25 coil cables (standard and D-coil), not very durable. If I start to sweat the OPUS 2 processor usually just stops working, so I put it into the dryer for a short time and it starts working again, hopefully with the 54 IP rating I will no longer have this problem. I am also very thankful for the new modular design, Currently the OPUS 2 has a strange design which uses connector pins to couple battery case to processor which also has a power switch, over time the connector pins and power switch become more rigid and the connection becomes unstable, The connector pins and power switch are gone with the SONNET, the battery cover powers it on and off and just pressing a button removes the battery frame (no more removing it manually). Quote Link to comment Share on other sites More sharing options...
HearPeers Heroes Adam Posted June 3, 2015 Author HearPeers Heroes Report Share Posted June 3, 2015 Great info Hadron. I am really looking forward to the increased water resistance as well as the new mics. But now we wait for the old FDA to start approving. If you do receive a sonnet before all the bells and whistles are approved, it is my understanding that MED-EL will also give the recipient a voucher to get the upgrades as soon as they pass the FDA Adam Quote Link to comment Share on other sites More sharing options...
HearPeers Heroes Adam Posted June 3, 2015 Author HearPeers Heroes Report Share Posted June 3, 2015 Hadron, also, welcome to hearpeers. We hope you stick around. Feel free to share what you feel comfortable with as far as your hearing journey or you in general. Adam Quote Link to comment Share on other sites More sharing options...
HearPeers Heroes Adam Posted June 3, 2015 Author HearPeers Heroes Report Share Posted June 3, 2015 Djr41180 check out the EAS forum on this page. It should give you some good info. Not necessarily on the sonnet, but on this technology itself and what people who have it, think about it Adam Quote Link to comment Share on other sites More sharing options...
HearPeers Heroes Ivana Marinac Posted June 4, 2015 HearPeers Heroes Report Share Posted June 4, 2015 Very nice studied problem by Hadron! Geek! By the way - welcome in the community... Quote Link to comment Share on other sites More sharing options...
lextender Posted May 11, 2016 Report Share Posted May 11, 2016 Does anybody know when the the second Sonnet microphone will be approved by the FDA? Quote Link to comment Share on other sites More sharing options...
HearPeers Heroes Mary Beth Posted May 11, 2016 HearPeers Heroes Report Share Posted May 11, 2016 No. Sorry. Quote Link to comment Share on other sites More sharing options...
HearPeers Heroes Mary Beth Posted May 11, 2016 HearPeers Heroes Report Share Posted May 11, 2016 The rechargeable Sonnet batteries and the waterwear for the Opus2/Sonnet have been reported to be seen as submitted to the FDA by a father of a Med-El user on another board. The DL-coil has already been FDA approved so we are waiting for Med-El to release them in the US. Quote Link to comment Share on other sites More sharing options...
HearPeers Heroes Adam Posted May 11, 2016 Author HearPeers Heroes Report Share Posted May 11, 2016 Nobody knows when the FDA approves. Usually they are pretty tight lipped about it. The CI companies don't really know either. They are waiting like the rest of us Quote Link to comment Share on other sites More sharing options...
lextender Posted June 1, 2016 Report Share Posted June 1, 2016 The Sonnet rechargeable battery, mini battery pack, cable and adapter were approved by the FDA on May 24. The application was submitted on February 29, 2016. Quote Link to comment Share on other sites More sharing options...
HearPeers Heroes Ivana Marinac Posted June 2, 2016 HearPeers Heroes Report Share Posted June 2, 2016 This is an update event, of course - the approval came few days ago... Quote Link to comment Share on other sites More sharing options...
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