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

Discussion in 'Research News' started by Tigo, Sep 11, 2018.

    1. Tigo

      Tigo Member

      Tinnitus Since:
      2 years
      Cause of Tinnitus:
      genetic hearing loss
      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
       
      • Informative Informative x 6
      • Like Like x 2
      • Winner Winner x 1
    2. Silvio Sabo
      Pooptoast

      Silvio Sabo Member Benefactor

      Location:
      Gothenburg, Sweden
      Tinnitus Since:
      05/2006
      Cause of Tinnitus:
      Noise - I think
      Could you post a link to the paper?
       
      • Agree Agree x 2
      • Like Like x 1
    3. Reinier
      Not amused

      Reinier Member Podcast Patron Benefactor

      Location:
      Netherlands
      Tinnitus Since:
      06/2015
      Cause of Tinnitus:
      Explosion starting engine
      I would like to know also the percentage of subjects that experienced improvement of their tinnitus.
       
      • Agree Agree x 2
      • Like Like x 1
    4. Contrast
      No Mood

      Contrast Member Benefactor Hall of Fame

      Location:
      Clown World
      Tinnitus Since:
      late 2017
      Cause of Tinnitus:
      noise injury
      • Good Question Good Question x 2
      • Like Like x 1
    5. Contrast
      No Mood

      Contrast Member Benefactor Hall of Fame

      Location:
      Clown World
      Tinnitus Since:
      late 2017
      Cause of Tinnitus:
      noise injury
      • Agree Agree x 5
      • Winner Winner x 2
      • Like Like x 1
      • Genius Genius x 1
    6. Frédéric

      Frédéric Member Podcast Patron Benefactor Advocate

      Location:
      Marseille, France
      Tinnitus Since:
      11/19/2012
      Cause of Tinnitus:
      acoustic trauma
      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/
       
      • Informative Informative x 1
      • Friendly Friendly x 1
    7. Daniel Lion
      Ape-like

      Daniel Lion Member Podcast Patron Benefactor Hall of Fame

      Location:
      SE Asia
      Tinnitus Since:
      2017
      Cause of Tinnitus:
      Noise trauma, hearing loss
      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.
       
      • Agree Agree x 1
    8. Frédéric

      Frédéric Member Podcast Patron Benefactor Advocate

      Location:
      Marseille, France
      Tinnitus Since:
      11/19/2012
      Cause of Tinnitus:
      acoustic trauma
      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
       
      • Informative Informative x 1
    9. Frédéric

      Frédéric Member Podcast Patron Benefactor Advocate

      Location:
      Marseille, France
      Tinnitus Since:
      11/19/2012
      Cause of Tinnitus:
      acoustic trauma
      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.
       

      Attached Files:

    10. tommyd87

      tommyd87 Member

      Tinnitus Since:
      1999
      Cause of Tinnitus:
      tmj music
      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.
       
      • Agree Agree x 1

Share This Page

Loading...