Round and Oval Window Reinforcement for the Treatment of Hyperacusis

[Marin]

In the patients I corresponded with / read posts on, history and outcome was a mixed bag:

Almost all of them had a history of some type of music / noise exposure / acoustic trauma that led to their hyperacusis. Many had lived with hyperacusis / tinnitus for many years (2+ years). They also seemed to have the most positive outcomes. Many have sustained their outcomes from following up on social media 2 - 5 years later.

There were a few that had hyperacusis for a surprisingly short time (6-9 months) before getting the surgery, which surprised me. Seems too soon; as I know personally that the disorder takes about a year to really stabilize. Some of those specific patients have not had as good as outcomes. From what I gather, they continued to go back to their pre-noise damaged ways, and re-injured their ears.

Wow, thank you so much for such an informative post!

It's very interesting to hear that the people who have had hyperacusis longer tended to have the more successful outcomes. I have wondered about the effect of the surgery on "newly" injured ears that still had active inflammation, and it seems like this answers my question.

I am looking forward to any other updates that you can provide on if it is reversible or not, and the impact it would have on one's ability to get regenerative meds in the future.

I'm also curious if Silverstein does anything else to make this surgery more effective for hyperacusis that a normal otologist couldn't do.

 

[chinup]

There's a pretty remarkable success story by a patient that basically got cured from his hyperacusis from this surgery.

View attachment 43584

Here is his LDL score before and one week after surgery:

View attachment 43596

A sometimes almost 30 dB improvement in pain/loudness threshold. That's insane.

Depending on how the FX-322 results turn out, I might take the chance and go do this. It doesn't affect tinnitus, but my hyperacusis is my biggest gripe at the moment. It's $8000.

But ideally you would want to get FX-322 first and then if your hyperacusis is not improved by it, go do this surgery afterwards.

Man I remember being in the exact same mental state as that guy and thinking that hyperacusis was the very worst thing that could happen to someone. Total despair.

But honestly I think bad tinnitus is even worse than bad hyperacusis, having had pretty intense cases of both conditions. The tinnitus just never stops... with hyperacusis you can at least hole up in a quiet room and read or watch TV with subtitles, you can go out into the woods all day with high caliber earplugs, stuff like that. There is literally no escape from screaming tinnitus at all.

Not to derail the thread or diminish hyperacusis, it's hell. Just crazy how what you think is the worst possible ear condition can get even worse.

 

[chinup]

Does anyone have a good reason why I shouldn't do it? I have pretty crippling hyperacusis, including pain and TTTS, all which seems to be resolved by this procedure according to the Silverstein Institute and the testimonials.

My only thought would be maybe to research the University of South Florida device that has been in trials before going under the knife. Not sure how effective it is but it's worth checking out and you can always have surgery as a last resort.

 

[chinup]

I've managed to correspond with the Silverstein Institute and a number of patients who have had the surgery over the past two years. I actually took their Hyperacusis Assessment, and plan to set an appointment with Dr. Silverstein or one of his associates.

I learned that nearly all patients had a "hypermotile" stapes joint, which was reinforced during the surgery with tissue. I also learned that multiple layers of tissue are applied to the oval and round window to reinforce + reduce vibration. It is the vibration from the combination of hypermotile stapes joint and activated nerves at the base of the cochlea which presumably causes some level of hyperacusis / pain irritation.

It appears that a few early patients actually returned to Silverstein to have additional layers of skin added. It looks like initially, they did 4 layers, in later patients it was increased to 6-8 layers.

In the patients I corresponded with / read posts on, history and outcome was a mixed bag:

Almost all of them had a history of some type of music / noise exposure / acoustic trauma that led to their hyperacusis. Many had lived with hyperacusis / tinnitus for many years (2+ years). They also seemed to have the most positive outcomes. Many have sustained their outcomes from following up on social media 2 - 5 years later.

There were a few that had hyperacusis for a surprisingly short time (6-9 months) before getting the surgery, which surprised me. Seems too soon; as I know personally that the disorder takes about a year to really stabilize. Some of those specific patients have not had as good as outcomes. From what I gather, they continued to go back to their pre-noise damaged ways, and re-injured their ears.

A couple had hyperacusis from medication. Really mixed bag here in terms of long-term recovery from the surgery.

Just wanted to share my findings. I am interested in the surgery, and will proceed with an appointment for Q&A. The multiple layers of tissue applied to the round window does give me pause, so I will ask about it.

I suspect that the procedure is not reversible, and if it is, there would have to be some scarring remaining. No patients that I could find have ever mentioned that they were told it was reversible.

Perhaps though, these intratympanic drugs like OTO-413, PIPE-505, & FX-322 will still be able to pass through a reinforced cochlea? I cannot find specific evidence to show that any of these drugs will pass through it.

Any update here?

I'm strongly considering this procedure at some point later in the summer or early fall. It seems minimally invasive, risk of upper frequency hearing loss is probably worth it to potentially sort out hyperacusis.

I'm interested to know if you ever heard back from them about the intratympanic drug issue?

I read an account somewhere today that said Silverstein told a patient that the procedure is reversible. I've been reading all day so sadly I'm not sure where that statement is, but when I read that I remembered this thread and there being some confusion about reversibility. I'll try to dig it up again.

The fact that virtually no one who has had this procedure can be tracked down is strange. There are a handful of positive accounts on Facebook if you dig around. There are also a couple of folks for whom the procedure did not work sadly. I wonder if we can infer from this that it works for most people and they simply move on with their lives and leave the forums behind?

 

[Greg B]

I was about to post a question regarding having the hyperacusis surgery and I see it's already discussed at length here.

I have my second discussion with the actual surgeon today. I met Dr. Silverstein by a Zoom appointment earlier this week.

My hyperacusis is a big problem in any setting with more than one person in the room, at a restaurant, can't even handle a hand clap in a room. I have worn earplugs to any situation where there will be any noise level above normal conversations and am just very tired of how debilitating this is.

And, as many have cited here, they focus on the ear that we think is the worst. It is clear for me with my left ear where the journey started first with a sinus infection, then a left ear infection. So my surgery will be on the left ear.

I'll be traveling to Sarasota to get my hearing tested to confirm hyperacusis levels that need surgery (so hopefully insurance covers it, which Dr. Silverstein said most do).

The next day they do a physical and prep, then on the third day they do the surgery, which will take about 30 minutes. I hope it works. And I hope I can confirm that indeed it helps those of us with this second layer of hell.

The numbers are encouraging. He's done about 60 surgeries now with a more than 80% success rate and no evidence that hearing will be compromised or, in the long run, the tinnitus would be worse after the surgery. Hope I have good news to report for all of us!

 

[100Hz]

I was about to post a question regarding having the hyperacusis surgery and I see it's already discussed at length here.

I have my second discussion with the actual surgeon today. I met Dr. Silverstein by a Zoom appointment earlier this week.

My hyperacusis is a big problem in any setting with more than one person in the room, at a restaurant, can't even handle a hand clap in a room. I have worn earplugs to any situation where there will be any noise level above normal conversations and am just very tired of how debilitating this is.

And, as many have cited here, they focus on the ear that we think is the worst. It is clear for me with my left ear where the journey started first with a sinus infection, then a left ear infection. So my surgery will be on the left ear.

I'll be traveling to Sarasota to get my hearing tested to confirm hyperacusis levels that need surgery (so hopefully insurance covers it, which Dr. Silverstein said most do).

The next day they do a physical and prep, then on the third day they do the surgery, which will take about 30 minutes. I hope it works. And I hope I can confirm that indeed it helps those of us with this second layer of hell.

The numbers are encouraging. He's done about 60 surgeries now with a more than 80% success rate and no evidence that hearing will be compromised or, in the long run, the tinnitus would be worse after the surgery. Hope I have good news to report for all of us!

Good luck with it. Would you mind asking them the burning question about the reversibility of the surgery (in the case that it did not work, and a drug was released in the future that required a semi-permeable round window for successful diffusion), I would really appreciate it.

I have seen it mentioned that its reversible but only on a patient testimony as a quote from a UK based journal, but not in any of the detailed Silverstein procedural papers I've read. I've been told in various ways, it 'may be possible', 'could be possible but not recommended' etc.

The part of the reinforcement procedure that concerns me is this - 'The mucosa of the round window niche and the stapes footplate was scraped with a micro pick to facilitate tissue welding.'

That sounds to me like at worst the reinforcement material could totally fuse to the round window membrane or could be removed but leaving some kind of impenetrable scar tissue behind, or at best be removed leaving the membrane in its original state. So if the surgery is even reversible, what state does it leave the membrane in and could a future drug still manage to diffuse through it?

What I would really like to know is if it matters at all and that the reinforced window would allow the diffusion as normal (saving the need for worrying about the reversal op at all).

I have tried to contact them twice with this question with no answer but as you're in dialogue with them maybe they'll be able to answer this. Thanks and best of luck with it.

 

[TheDanishGirl]

I am still keeping this surgery in my backup plan, but I am worried about what meds it requires both before and after. As we all know, meds always come with risks.

 

[Mary97]

@Greg B good luck! Fingers crossed for you. I had to chuckle reading your post. Please keep us informed and I pray for a wonderful outcome for you.

 

[Philip83]

I am worried about what meds it requires both before and after.

What meds do you mean?

 

[Philip83]

What I would really like to know is if it matters at all and that the reinforced window would allow the diffusion as normal (saving the need for worrying about the reversal op at all).

I have tried to contact them twice with this question with no answer but as you're in dialogue with them maybe they'll be able to answer this. Thanks and best of luck with it.

I've also tried to contact them twice with this question without any response. My guess is they don't know for sure and that refraining from replying simply doesn't start any FUD about it. Hopefully we can find out though!

I wonder if it would maybe be possible to only stabilise the stapes bone and not reinforce the round window, and if that would at least have some effect on hyperacusis? From what I understand, the stapes bone stabilising is only done as an "optional" procedure during the surgery, if they see if it's actually loose or not.

 

[TheDanishGirl]

What meds do you mean?

Pain killers, sedatives or whatever else is required during the surgery and after.

 

[Marin]

I wonder if it would maybe be possible to only stabilise the stapes bone and not reinforce the round window, and if that would at least have some effect on hyperacusis? From what I understand, the stapes bone stabilising is only done as an "optional" procedure during the surgery, if they see if it's actually loose or not.

From what I've read from people who have had the surgery, stabilizing the stapes helped with low rumbling and vibrational sounds like car exhausts. If you are sensitive to high frequencies, I think you'd still need the round oval part of the surgery.

 

[Philip83]

I was about to post a question regarding having the hyperacusis surgery and I see it's already discussed at length here.

I have my second discussion with the actual surgeon today. I met Dr. Silverstein by a Zoom appointment earlier this week.

My hyperacusis is a big problem in any setting with more than one person in the room, at a restaurant, can't even handle a hand clap in a room. I have worn earplugs to any situation where there will be any noise level above normal conversations and am just very tired of how debilitating this is.

And, as many have cited here, they focus on the ear that we think is the worst. It is clear for me with my left ear where the journey started first with a sinus infection, then a left ear infection. So my surgery will be on the left ear.

I'll be traveling to Sarasota to get my hearing tested to confirm hyperacusis levels that need surgery (so hopefully insurance covers it, which Dr. Silverstein said most do).

The next day they do a physical and prep, then on the third day they do the surgery, which will take about 30 minutes. I hope it works. And I hope I can confirm that indeed it helps those of us with this second layer of hell.

The numbers are encouraging. He's done about 60 surgeries now with a more than 80% success rate and no evidence that hearing will be compromised or, in the long run, the tinnitus would be worse after the surgery. Hope I have good news to report for all of us!

When will your surgery take place?

 

[Damocles]

Pain killers, sedatives or whatever else is required during the surgery and after.

Yeah, it'll just be a combination of some painkillers with an antibiotic.

Post-operative care is usually pretty routine.

Unless you're allergic to penicillin and/or all the other non-ototoxic antibiotics, then the meds after surgery should be the least of your concerns.

 

[Brian Newman]

I've managed to correspond with the Silverstein Institute and a number of patients who have had the surgery over the past two years. I actually took their Hyperacusis Assessment, and plan to set an appointment with Dr. Silverstein or one of his associates.

I learned that nearly all patients had a "hypermotile" stapes joint, which was reinforced during the surgery with tissue. I also learned that multiple layers of tissue are applied to the oval and round window to reinforce + reduce vibration. It is the vibration from the combination of hypermotile stapes joint and activated nerves at the base of the cochlea which presumably causes some level of hyperacusis / pain irritation.

It appears that a few early patients actually returned to Silverstein to have additional layers of skin added. It looks like initially, they did 4 layers, in later patients it was increased to 6-8 layers.

In the patients I corresponded with / read posts on, history and outcome was a mixed bag:

Almost all of them had a history of some type of music / noise exposure / acoustic trauma that led to their hyperacusis. Many had lived with hyperacusis / tinnitus for many years (2+ years). They also seemed to have the most positive outcomes. Many have sustained their outcomes from following up on social media 2 - 5 years later.

There were a few that had hyperacusis for a surprisingly short time (6-9 months) before getting the surgery, which surprised me. Seems too soon; as I know personally that the disorder takes about a year to really stabilize. Some of those specific patients have not had as good as outcomes. From what I gather, they continued to go back to their pre-noise damaged ways, and re-injured their ears.

A couple had hyperacusis from medication. Really mixed bag here in terms of long-term recovery from the surgery.

Just wanted to share my findings. I am interested in the surgery, and will proceed with an appointment for Q&A. The multiple layers of tissue applied to the round window does give me pause, so I will ask about it.

I suspect that the procedure is not reversible, and if it is, there would have to be some scarring remaining. No patients that I could find have ever mentioned that they were told it was reversible.

Perhaps though, these intratympanic drugs like OTO-413, PIPE-505, & FX-322 will still be able to pass through a reinforced cochlea? I cannot find specific evidence to show that any of these drugs will pass through it.

Did you end up doing it yet, Diesel ? I live 2 hours from Sarasota, I'm seriously considering it.

 

[Philip83]

I will soon have a Zoom meeting with the Silverstein Institute about my situation with hyperacusis. Anyone has any questions you want me to ask?

 

[Damocles]

I will soon have a Zoom meeting with the Silverstein Institute about my situation with hyperacusis. Anyone has any questions you want me to ask?

Just the thing about reversing the procedure, if necessary.

And if the OVR offers any hearing protection. For example: would this make wearing earplugs in moderately noisy places unnecessary, or would hearing damage — in less than severely noisy environments — (for those of us whose hearing is already compromised) still occur?

 

[chinup]

I will soon have a Zoom meeting with the Silverstein Institute about my situation with hyperacusis. Anyone has any questions you want me to ask?

Along with the questions Damocles has presented, I was wondering if they have any suggestions on when to resume activities like listening to music and playing musical instruments (both at safe volume levels).

I know it's kind of a subjective question, everyone heals differently, but I was just wondering if they've perhaps had patients who were musicians and who have successfully resumed their music careers, and maybe some advice on how to approach reintroducing these louder sounds (if possible).

 

[Brian Newman]

I will soon have a Zoom meeting with the Silverstein Institute about my situation with hyperacusis. Anyone has any questions you want me to ask?

Let us know how it goes man!

 

[Philip83]

I was about to post a question regarding having the hyperacusis surgery and I see it's already discussed at length here.

I have my second discussion with the actual surgeon today. I met Dr. Silverstein by a Zoom appointment earlier this week.

My hyperacusis is a big problem in any setting with more than one person in the room, at a restaurant, can't even handle a hand clap in a room. I have worn earplugs to any situation where there will be any noise level above normal conversations and am just very tired of how debilitating this is.

And, as many have cited here, they focus on the ear that we think is the worst. It is clear for me with my left ear where the journey started first with a sinus infection, then a left ear infection. So my surgery will be on the left ear.

I'll be traveling to Sarasota to get my hearing tested to confirm hyperacusis levels that need surgery (so hopefully insurance covers it, which Dr. Silverstein said most do).

The next day they do a physical and prep, then on the third day they do the surgery, which will take about 30 minutes. I hope it works. And I hope I can confirm that indeed it helps those of us with this second layer of hell.

The numbers are encouraging. He's done about 60 surgeries now with a more than 80% success rate and no evidence that hearing will be compromised or, in the long run, the tinnitus would be worse after the surgery. Hope I have good news to report for all of us!

Any news to report @Greg B?

 

[mohn]

@Philip83 - question to get advice. Actual sound decibel versus perceived loudness - hyperacusis sufferers will hear sound louder than what decibel it actually is.

Can 70 decibel noise hurt hyperacusis sufferers (causing inner ear hair cell issues) while it does not hurt normal ears?

Also, why do hyperacusis sufferers get spikes even from low decibels noises that normal people have no bad effect from?

 

[Mrkbek]

Hello everyone - I've just posted my review on this surgery in my own thread. Please feel free to continue discussion on my thread or here as well. Thank you!

REVIEW: Round and Oval Window Reinforcement Surgery for Hyperacusis — The Silverstein Institute

 

[GoatSheep]

I was about to post a question regarding having the hyperacusis surgery and I see it's already discussed at length here.

I have my second discussion with the actual surgeon today. I met Dr. Silverstein by a Zoom appointment earlier this week.

My hyperacusis is a big problem in any setting with more than one person in the room, at a restaurant, can't even handle a hand clap in a room. I have worn earplugs to any situation where there will be any noise level above normal conversations and am just very tired of how debilitating this is.

And, as many have cited here, they focus on the ear that we think is the worst. It is clear for me with my left ear where the journey started first with a sinus infection, then a left ear infection. So my surgery will be on the left ear.

I'll be traveling to Sarasota to get my hearing tested to confirm hyperacusis levels that need surgery (so hopefully insurance covers it, which Dr. Silverstein said most do).

The next day they do a physical and prep, then on the third day they do the surgery, which will take about 30 minutes. I hope it works. And I hope I can confirm that indeed it helps those of us with this second layer of hell.

The numbers are encouraging. He's done about 60 surgeries now with a more than 80% success rate and no evidence that hearing will be compromised or, in the long run, the tinnitus would be worse after the surgery. Hope I have good news to report for all of us!

Did you get the surgery @Greg B?

 

[Taw]

Did you get the surgery @Greg B?

Unfortunately that was his last post on this forum. I hope that he is doing well.

 

[Greg B]

Hey hey folks. Sorry I didn't follow up here.

I didn't get the surgery. The surgery was $8,000 and insurance didn't pick it up. And frankly I was a little worried about the effects. Apparently there is a spike for a bit after the surgery which is understandable with the activity going on there. And I was worried it would stick, especially as I had been dealing with a new "drone" sound on top of the normal hissing and tone.

The doctors and staff were very nice and am sure do a great job.

I'm just now hoping on Neuromod getting approval in the States for a more direct attempt at helping the condition.

Sorry again for not following up and hope everyone is hanging in okay.

 

[nogg]

I've been curious about this surgery. It seems that it might help when the stapes bone is hypermobile. Certainly, that could happen with something like an auto accident or maybe a loud impact noise. But other causes of hyperacusis I'm not so sure about.

It would be nice if there was a noninvasive test to determine the stapes mobility and whether the surgery would help, but apparently not.

My left ear has always been the most sensitive one, so if it could address that ear then I would be interested, but only if hypermobility of the stapes is the actual problem. If the problem is a loss of OHC, then the surgery wouldn't directly address that.

 

[VeryUnfortunate]

Does anyone know of anyone who has had this surgery done in California?

 

[addot]

I am once again considering this surgery, now more seriously than ever. My impressions are the same ones already discussed here: many people seem to improve (although how much improvement ranges from minimal to life-changing), some people report no change, and, alarmingly, at least a few people got worse from it. Silverstein's most recent publication (2020) on the subject rates the success rate at 80%, although it seems that count doesn't include people with who Silverstein couldn't follow up after the surgery. Which is understandable, but it's always possible that these people had negative (or neutral) results which could bring the success rate down. It still feels like a gamble... and an expensive one, at that.

Weirdly enough that isn't even my biggest concern. What really makes me hesitate is the possibility that the surgery can hinder the inner ear regeneration drugs that might come out. Pretty much all of these involve drug diffusion across the round window... I'm not sure how well they'd diffuse across 6-8 extra layers of tissue. I am thinking of asking that question to both Silverstein and to Frequency Therapeutics and Otonomy. I'm not holding my breath though: Silverstein hasn't responded other people who asked the same question, and in any case it's well possible (if not very likely) that this question is fundamentally impossible to answer, as FX and OTO are still in trials and there's almost certainly no data about drug diffusion into a reinforced round window. Not only that, regardless of diffusion, although we all want these drugs to succeed, we don't know when or even if they will (or even if they will help hyperacusis if they work for hearing loss).

Should I put off surgery that could give me immediate relief for something that I'm not sure would help me? I truly, truly don't know the answer to that.

 

[LilCC]

@addot, I'm in the same boat!

 

[Shizune]

What really makes me hesitate is the possibility that the surgery can hinder the inner ear regeneration drugs that might come out. Pretty much all of these involve drug diffusion across the round window... I'm not sure how well they'd diffuse across 6-8 extra layers of tissue. I am thinking of asking that question to both Silverstein and to Frequency Therapeutics and Otonomy. I'm not holding my breath though: Silverstein hasn't responded other people who asked the same question, and in any case it's well possible (if not very likely) that this question is fundamentally impossible to answer, as FX and OTO are still in trials and there's almost certainly no data about drug diffusion into a reinforced round window. Not only that, regardless of diffusion, although we all want these drugs to succeed, we don't know when or even if they will (or even if they will help hyperacusis if they work for hearing loss).

Should I put off surgery that could give me immediate relief for something that I'm not sure would help me? I truly, truly don't know the answer to that.

I consulted with Silverstein last March and asked about FX-322/intratympmanic injections. He said the procedure has been updated to leave the round window open, meaning the procedure wouldn't prevent you from having injections in the future. Whether leaving the round window open but reinforcing the rest lessens the effects of the surgery or not, I don't know.