Lenire — Bimodal Stimulation Treatment by Neuromod

@Krolo,

Why is your pickup date of the device so late? (2 months after!)

They first said it would be 2 weeks after the 1st appointment...

 

@Krolo,

In my right ear I can't hear above 16 kHz (18 kHz and 20 kHz).

Can this disqualify me?

I was hoping that they didn't measure such high frequencies

 

I thought humans don't hear over 16 kHz.

I just tried the highest I can hear is 16.5 kHz - even my teenage brother with perfect hearing wasn't able to hear that.

 

I hear nothing above 16 kHz and it didn't disqualify me. Don't worry.

 

A brief summary of my first visit, focusing on stuff I don't recall seeing posted:

• The visit inspired further confidence in Neuromod. They have a modern, neat location, their staff is super nice, courteous and professional.
• My follow-up is on November 5. This was the earliest free slot available. Neuromod maintains free slots for follow-up customers in their calendar so you are pretty much guaranteed to get one in 4-6 weeks. Further appointments are precisely 6 weeks after each other. The reason I got an earlier date than @Krolo is simple luck: I finished an hour before him and was offered the earlier one.
• Using the device at the same time each day is recommended but not mandatory. You can deviate from that. What really matters is that you get the 1 hour total in every day.
• You're free to use the device beyond 12 weeks. This was just an arbitrary cutoff date in the studies, and has no biological or scientific meaning. In fact the audiologist seemed confident that if Lenire is used long enough, even weak responders should be able to get results. You can go on pretty much indefinitely. (Keep in mind though, that the tonguetip has to be replaced every 180 hours.)
• Neuromod is seriously considering providing software updates to the device later, as experience is gained and better signaling protocols are developed.
• The evaluation criteria for fitness were 1. level of hearing loss 2. psychological stability in my case. No new criteria were mentioned and I specifically asked.
• The Neuromod staff are aware of Tinnitus Talk, our frenzied desire for a treatment, and the emotional rollercoaster these threads produce. They appear to be occasional visitors but generally stay away and focus on their jobs. Which is IMO the right thing to do.

Overall I'm smiling as I type this. Finally meeting a doctor who really is knowledgeable about tinnitus and offered a realistic (through not guaranteed!) treatment option was a true relief after years of "just live with it".

 

Good for you @hans799. Keep us posted and best of luck.

 

@hans799 thanks very much for the update. I really do wish you and @Krolo the best of luck in your treatment.

Hopefully you'll both enjoy good results, which will also give those of us that have been "tinnitized" for decades useful data when assessing the Lenire device.

 

Pretty sure they aren't testing beyond 8 kHz.

Most people over age 30 can't hear much past 16 kHz.

 

The regular test I presume is up to 8 kHz. I specifically asked about a 16 kHz test since when I got my extreme tinnitus I had a deaf zone around 12-14 kHz and wanted to get that tested in a proper setting and not me sitting with speakers.

I will also reiterate @hans799's points regarding eligibility. Hearing loss is 1st and 2nd is your mental state.

 

It's strange why they haven't tested the device for longer than 3 months. One possible answer is that they want to see if 3 months treatment is sustainable after a year for which the answer was yes, it was sustainable. But nevertheless, they could use a subset of patients and make their treatment 6 months and see how the results differ between 3 and 6 months.

 

Out of curiosity, how was that measured? Was some special kind of equipment used?

 

They basically use standard audiology equipment. But they can go up into the higher frequencies. Also I had a test first that was the regular tone type of test and then one that had a vibrator type of sound which made it easier to distinguish through all the tinnitus that I get. My tinnitus is quite severe but my hearing loss is in normal range.

 

So they did an audiogram up to 16 kHz? Not the regular audiogram, but with high frequencies?

 

What type of tests/questions did Neuromod ask to figure out other causes that may disqualify someone from using Lenire? Based on the sample here, it seems that the only people who were disqualified had moderate/severe hearing loss or did not have tinnitus long enough.

 

They don't test the very high frequencies as they accept losses of up to 80 dB from 2 kHz to 8 kHz. I can't hear anything above 9 kHz and I imagine no one above 50 would be able to use Lenire otherwise.

From an earlier post:
Please note that Lenire® can only be recommended for you if you have hearing level (AC pure tone audiometry) thresholds of no more than 40 db HL at 250 Hz, 500 Hz and 1000 Hz, and not more than 80 db HL at 2000 Hz, 3000 Hz, 4000 Hz, 6000 Hz and 8000 Hz in either ear at one frequency or more. You may want to consult your audiologist before accepting an appointment if you are unsure of your hearing level thresholds. If you have a copy of your Pure Tone Audiogram, please bring it with you if you accept an appointment with Neuromod Medical.

The following illustration may be informative; if a patient’s audiogram dips below the red/blue lines at any point for either ear, then Lenire® cannot be configured for their hearing profile.

 

I would like to ask someone, when they have their appointment, to query the consultant as to why someone with disqualifying hearing loss, but who wears hearing aids, cannot still use Lenire.

It doesn't seem to be a precluding factor for Susan Shore's device as far as I can tell. At least not yet.

I have emailed Neuromod weeks ago with this question, but have received no reply to date.

 

For mental stability, they look at your TFI and medical history (how you got tinnitus etc). Having a bad spike and freaking out about it won't disqualify you (I shared with them that I felt incredibly low for months after my 2017 spike) - only if the freakout is still ongoing, because then they need to address that first.

For hearing, they do a standard audiogram, physically look into your ears, and take MML.

I think they'll also add more tests into the battery if warranted, for example @Krolo's audiogram went higher than mine did.

 

Excellent, but one question. How is the mental state assessed? With a questionnaire?

 

What sound are you getting installed?

 

I just received an email this morning from Neuromod asking me to send in my most recent audiogram. My appointment is in mid-November. The email stated that this is so their audiologist can review your hearing results before your appointment to allow a more efficient visit.

@GlennS just tagging you on this so you are aware, but I am guessing you received the email as well.

 

@jmasterj,

I received the email as well...

My appointment is mid-October.

I think it's also about them being able to exclude people with too much hearing loss so they don't go to Dublin for nothing, don't you think so too?

 

I would assume so Alice. The only other thing I could think of is that they are trying to streamline the appointment to get more people through, so if you have a recent audiogram they wouldn't require another one at your appointment.

 

I've been on the waiting list since July. By the time I'm invited, the rose tinted spectacles will be taken off. Another 4 months before the verdicts unfold. I'll keep praying.

 

It’ll be sooner than that. The first patients began receiving their Lenires after July 17th. The verdicts should be in by the end of September to mid-October.

 

I did. It sure seems like they're paying attention to feedback, whether they are in fact lurking in this thread or getting the same sort of feedback through other channels. If my audiogram looks bad I am definitely going to pressure them to pre-screen me on that alone so I don't wind up wasting a trip.

 

A questionnaire and I guess it's depending on what you state.

 

Just don't walk in looking like this.

 

That's what I imagined, but knowing this I think we will be all very careful about how we look like and what we write in the questionnaire.

 

@jmasterj

I think they will do another audiogram anyway at the appointment because results can be different between 2 audiogram devices...

 

In this case what would be the point of sending them an audiogram upfront if they were to do it on-site anyway?