Totally Implantable Active Middle Ear Implant: Hearing and Safety Results in a Large Series

Abstract
Objectives
To evaluate hearing performance and safety measures in a large group of totally implantable active middle ear implant (AMEI) wearers.

Methods
Retrospective case review of 172 ears (166 patients) with sensorineural hearing loss undergoing implantation of a totally implantable AMEI. Pure‐tone air and bone thresholds, pure‐tone average, speech reception threshold (SRT), and word recognition scores (WRS) at phonetically balanced maximum and at 50 dB (WRS50) were assessed at baseline unaided, with a hearing aid (baseline aided [BLA]), with the implant at activation, and for best implant postoperative measurement. Adverse events were reviewed.

Results
Mean length of follow‐up was 35.7 months. Compared to unaided, the implant provided significant gain at all frequencies through 6 kHz. Amount of gain was significantly better with the implant than BLA at 1,500 and 2,000 Hz (P ≤ .001). Implant SRT was also significantly improved compared to BLA (29.9 dB vs. 38.5 dB, P ≤ .001). At a 50‐dB presentation level, WRS was significantly better with the implant than BLA (65.6% vs. 45.5%, P ≤ .001). Bone conduction thresholds were not affected by the implant. The most common adverse event was taste disturbance, which occurred in 39.1%. In subjects with preimplant tinnitus, 56.1% experienced resolution of their tinnitus. Revision surgery was required in 15.7%, and 4% were ultimately explanted.

Conclusion
The implant provided significant hearing benefit compared to unaided and to the subjects' own hearing aids in most test categories, with minimal adverse events. Many subjects experienced complete resolution of their tinnitus after implantation.

Level of Evidence
4. Laryngoscope, 2018

 

Could you post a link to the paper?

 

I would like to know also the percentage of subjects that experienced improvement of their tinnitus.

 

56% had complete resolution, how many had a tinnitus reduction?

 

this only shows evidence that curing hearing loss will cure tinnitus

 

The Esteem®, Fully Implantable Middle Ear Device

Abstract
The active middle ear implant (AMEI) may be considered, in selected cases, a valid alternative to conventional hearing aids (cHA) for rehabilitation of bilateral sensorineural hearing loss (SNHL). Since 2007, at the Implanting Centre of the University Hospital Sant’Andrea in Rome, 43 subjects underwent surgery for application of the Esteem®, after ascertaining by CT scan its feasibility for allocating its transducers within the mastoid space. The surgical procedure is longer than for the other AMEI, and the switch on of the device is usually performed 4–6 weeks after surgery. All the Esteem® implantees underwent a pre- and postoperative assessment via pure tone and speech audiometry with headset in a soundproof booth. Along with the recommended population with moderate-to-severe hearing loss, subjects also with a worse hearing loss (severe or severe-to-profound) were selected for this implant for different reasons. The auditory outcome in label and off-label implantees was analyzed. Complications included the need for a minor revision, due to middle ear fibrosis, or for an explant that was followed by ossicular reconstruction with return to a cHA (two subjects), cochlear implantation (five subjects) or no alternative solution (one case).

Full text: https://www.intechopen.com/online-first/the-esteem-fully-implantable-middle-ear-device

I also found the company website for those who are interested: https://esteemhearing.com/

 

Fascinating... I was impressed that you can use them in water...

Sound like the technology is getting more sophisticated... I wonder why Rome was the testing center... pretty exciting to see where this goes... more hope that’s for sure.

 

I don't know wether it needs to be in a new thread or it can be posted in this one (+ I thought it was for conductive hearing loss and not sensorineural hearing loos):

Effects of Vibrant Soundbridge on tinnitus accompanied by sensorineural hearing loss

Abstract
Objectives
Tinnitus is a common symptom among patients with hearing loss, and many studies have reported successful tinnitus suppression with hearing devices. Active middle ear implantation of the Vibrant Soundbridge (VSB) is a good alternative to existing hearing devices. This study evaluated the effects of VSB implantation on tinnitus and sought to identify the main audiological factor that affects tinnitus suppression.

Methods
The study participants were 16 adults who had tinnitus with sensorineural hearing loss, and who underwent VSB implantations. Pure-tone audiometry; word recognition test; tinnitus handicap inventory (THI); and visual analog scale (VAS) assessment of loudness, awareness, and annoyance were performed before and 12 months after surgery. Changes in hearing threshold, word recognition scores (WRS), THI scores, and VAS scores were analyzed.

Results
VAS scores for loudness (mean difference: 1.9, 95% CI: 0.6, 3.1), awareness (mean difference: 1.6, 95% CI: 0.4, 2.8), and annoyance (mean difference: 1.7, 95% CI: 0.7, 2.8) showed significant improvements from baseline to 12 months after surgery. In addition, THI scores showed a significant decrease (mean difference: 13.8, 95% CI: 2.9, 24.9). The average hearing threshold level, WRS, and most comfortable level (MCL) also showed significant improvements at 12 months after surgery (mean difference: 17.3, 95% CI: 13.3, 21.3; mean difference: −7.6, 95% CI: −15.1, −0.1; mean difference: 26.3, 95% CI: 22.9, 29.6, respectively). Among the aforementioned factors, changes in MCL were best correlated with those in THI scores (mean difference: 2.55, 95% CI: 0.90, 4.21).

Conclusion
A VSB implant is beneficial to subjects with tinnitus accompanied by sensorineural hearing loss. The changes in THI scores best correlated with those in MCL. This improvement may represent a masking effect that contributes to tinnitus suppression in patients with VSB implants.

Full article: https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0228498

See also:
https://www.medel.com/ca/

Key features of the SOUNDBRIDGE implant

 

Another way to hear: bone conduction implant. It is a pity that the full article is not in English. May be later it will be released in English.

Link to one of the described products: https://www.medel.com/en-us/hearing-solutions/bonebridge
There is a good video to explain the process.

Efficacy of Implantable Bone Conduction Hearing Aids in Single-Sided Deafness

As the technology advances and bone conduction implant (BCI) use increases, implantable bone conduction hearing aids are regarded as a treatment method for single-sided deafness (SSD) and their efficacy on SSD must be discussed. Therefore, we organized the problems of SSD and types of implantable bone conduction hearing aids and explained their effectiveness in the treatment of SSD in terms of changes in 1) speech recognition in a noisy environment, 2) sound localization, 3) subjective satisfaction as assessed by questionnaire, and 4) tinnitus. Although bone conduction hearing aids do not significantly improve localization ability in SSD, they increase the ability to listen under noise, increasing subjective satisfaction. Tinnitus improvement was also reported. The active forms of BCI like MED-EL BONEBRIDGE® 2 and Cochlear Osia® 2 have been developed well. Based on these technological developments and effects, bone conduction hearing aids would be a good option for treatment option of SSD.

 

I think this is why there is so much plausibility that a treatment like FX-322 will work with reducing tinnitus as long as it is able to get in the ear and correctly activate hair cell regrowth like it did in the lab work trials.