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Yes, Trump wants Americans to have access to treatments and medicines that can help us. Despite what the liberal media says, he is focused on what is best for the people!

That’s my understanding as well.

Finally, a large company is evaluating cochlear implants.

Once again, something happened. If you recall, it was the pandemic that delayed their most recent clinical trial.

Will we be able to watch a replay of the Q&A?

I would like to say that Dr. Shore did communicate with us. She did a whole Q&A with us! → Q&A with Dr. Shore She just won’t comment on the FDA process.

Did they say what criteria the 10% meets? That would be helpful.

Does this change your opinion about Lenire at all?

In Dr. Shore's clinical trial(s), the patient population was kind of small compared to Lenire. Dr. Hubert Lim also said that you really can’t have a true placebo with a device like Lenire because people can tell if they are not getting the electric stimulation. This might be the same with Auricle.

After listening to the aforementioned recent interview of Neuromod's Dr. Hubert Lim, I wouldn’t be surprised if the FDA asked Auricle for an additional clinical trial.

Yup.

Their second clinical trial was pushed back due to the pandemic. You may have heard about it. It was called the COVID-19 pandemic.

99% of the posts on this thread.

Does anyone really care what some random on Tinnitus Talk says? All we can do is wait and hope to hear about FDA approval.

I took part in the study as well. I’m almost certain I got the placebo headphones.

Thank you @Markku for following up! Appreciate you!

I think this, or Dr. Hamid Djalilian’s work is the most promising. He drew up a mock of a potential device. @Markku, has anyone reached out to Dr. Hamid Djalilian regarding the status of his device?

Because they needed funding.

At least we know they have the funding.

I wonder if they will ever look to expand the criteria for people who just fall outside of the requirements for a cochlear implant.

If the monkeys had passed away from Neuralink, the FDA wouldn't let him test it on humans.

You’ve been on here for a couple months lol.

Money bags.

Looks like there is a follow-up study on this but it is behind a paywall: → A Digitally-Controlled Integrated Circuit Solution for Tinnitus Treatment with Charge Balancing

The reason they tested people with somatic tinnitus was because they could prove a connection with the dorsal cochlear nucleus I believe.

I can’t believe no one saw this back in September?!?! This is good news but you can’t tell by the comments.

Did he provide any information regarding clinical trials?

Statements like yours are ridiculous. Dr. Shore has stated that Auricle are in the process of working with the FDA to get approval. She has retired and has stated that she is focusing on getting this device ready for commercialization. Yes, we don’t have a release date, but to say it won’t ever...

I posted on here a while ago how they were having a hard time recruiting. I contacted them about a year ago and they were still accepting but I was excluded due to the medication. People here need to be more proactive about signing up for the clinical trials.

What were you expecting to hear? That sounds pretty good to me. They have all the people enrolled and they will complete the trial. If the results are good, they may not have to do another trial.

It hasn’t even been six months since the study was published.

Guys, if it becomes available in the US only, I’ll let you stay at my house for your appointment.

They are doing a clinical trial for Lidocaine at Mass Eye and Ear. After the injection you undergo an MRI to analyze the brain.

I don’t know if Neuromod stated exactly when they submitted but they said they were waiting on FDA approval. They also opened up US headquarters anticipating approval. She literally did not answer the question.

Can anyone clarify this for us?

How come no one is focusing on the two subjects who had their tinnitus go away?!

Imagine being the two patients whose tinnitus went completely away and they can’t have the device!

It will probably only work for acute tinnitus.

She said they didn’t test Meniere’s patients because they have intermittent tinnitus. She never said it wouldn’t work for intermittent tinnitus.

I don’t know why it’s so hard to understand she can’t answer hypothetical questions because she doesn’t have the evidence to back it up.

I knew people were gonna ask irrelevant questions.

Neuromod doesn’t claim Lenire lowers tinnitus loudness. Leave it alone.

I’ve applied for this like 3 times. Never got a response.

They didn’t receive the electrical stimulation.

Pfizer was already a pharmaceutical giant before COVID-19.

Remember not to ask questions that she won’t be able to back up with evidence from the clinical trials. She will not speculate in my opinion. @Markku, did you get any info if the FDA process has begun?

@Karl Tallman, I think initially they were planning a 400 person trial but then COVID-19 happened.

So they don’t have to agree with the conclusion that is published?

I think that’s what the people who peer reviewed the results did.

No, if anything, Dr. Shore thought the results were sooooo promising that she retired and will double dip on her income from Auricle and her pension. Your reasoning doesn’t make sense and only a paranoid person would think that. Do we know if they have submitted an application to the FDA?

Two were discussed at the conference. Neosensory and Dr. Shore's device.

I’m 40 and I wear a hearing aid. No one says anything, and who cares if they do. A lot of people wear ear wearables anyways.

There’s gating areas in the brain that shut down the tinnitus for some people. In people who have tinnitus, those gating areas don’t work for some reason. I believe Dr. Rauschecker talks about this in his TED talk. So, yes, ultimately it starts because of the lack of input from the cochlea but...

San Francisco, CA.

@Hazel, are we going to be provided with any more interviews from this conference? Any updates from Dr. Rauschecker?

Yes, that’s what I’ve heard. Your brain adjusts. It takes practice.

Actually people do who fit the criteria.

Where are these studies you speak of?

From the study:

That’s what I said.