Skip to main content
SpringerLink
Log in

The first results of a totally implanted active middle ear device

  • Otology
  • Published:
European Archives of Oto-Rhino-Laryngology Aims and scope Submit manuscript

Abstract

Purpose

The aim of this study was to assess the first outcomes of a fully implantable active middle ear device.

Methods

Retrospective observational nonrandomized group study. Settings: Private hospital. Fifteen patients underwent device implantation between December 2014 and June 2017. The pre-operative and post-operative air conduction (AC) and bone conduction (BC) thresholds were evaluated. The functional gain, speech perception in silence and in noise, and localization abilities were also analyzed.

Results

Sixteen active middle ear implantations were performed. Post-operatively, the mean pure tone thresholds were 50.5 dB ( ± 12.64) for BC and 64.9 dB ( ± 15.36) for AC. No differences were found between the post-operative and pre-operative audiometric thresholds before activating the system (p > 0.05). Post-operatively, the mean thresholds in the free field after the device was activated were 46.8 dB, 45.75 dB, 42.6 dB, and 43.38 dB at 1, 3, 6, and 12 months, respectively. The global results of speech understanding in silence were 50.7 dB, 47.18 dB, 42 dB, and 42 dB for 1, 3, 6, and 12 months, respectively. Patients with mixed hearing loss had better results than those with sensorineural hearing loss. Speech discrimination in noise and localization was improved.

Conclusions

Despite the small number of patients, our results confirmed that this fully implantable active middle ear device is a viable treatment for patients with moderate-to-severe sensorineural hearing loss who cannot or do not want to use traditional hearing aids for clinical or cosmetic reasons.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Fig. 1

Similar content being viewed by others

References

  1. Ernst A, Todt I, Wagner J (2015) Safety and effectiveness of the Vibrant Soundbridge in treating conductive and mixed hearing loss: a systematic review. Laryngoscope 126:1451–1457

    Article  Google Scholar 

  2. Bruschini L, Forli F, Santoro A et al (2009) Fully implantable Otologics MET CarinaTM device for the treatment of sensorineural hearing loss. Preliminary surgical and clinical results. Acta Otorhinolaryngol Ital 29:79–85

    PubMed  PubMed Central  CAS  Google Scholar 

  3. Bittencourt AG, Burke PR, Jardim IS et al (2014) Implantable and semi-implantable hearing aids: a review of history, indications, and surgery. Int Arch Otorhinolaryngol 18:303–310

    Article  Google Scholar 

  4. Zwartentok JW, Mulder JJS, Snik Ad FM et al (2016) Active middle ear implantation: long-term medical and technical follow-up, implant survival, and complications. Otol Neurotol 37:513–519

    Article  Google Scholar 

  5. Traynor RM, Fredrickson JM (2007) The future is here: the otologics fully implantable hearing system https://www.audiologyonline.com/articles/future-here-otologics-fully-implantable-928. Accessed 1 Jan 2017.

  6. George L (2006) Report of the medical technology assessment working group. Duke University, Durham, New York

    Google Scholar 

  7. Fredrickson JM, Coticchia JM, Khosla S (1996) Current status in the development of implantable middle ear hearing aids. Adv Otol 10:189–204

    Google Scholar 

  8. Bruschini L, Forli F, Passetti S et al (2010) Fully implantable Otologics MET Carina™ device for the treatment of sensorineural and mixed hearing loss: audio-otological results. Acta Otorhinolaryngol Ital 130:1147–1153

    Article  Google Scholar 

  9. Jenkins HA, Atkins JS, Horlbeck D et al (2008) Otologics fully implantable hearing system: phase I trial 1-year results. Otol Neurotol 29:534–541

    Article  Google Scholar 

  10. Fredrickson J, Cotcchia J, Kohosla S (1995) Investigations into an implantable electromagnetic hearing device for moderate to severe sensorineural loss. Otolaryngol Clin North Am 28:107–120

    PubMed  CAS  Google Scholar 

  11. Rameh C, Meller R, Lavieille JP et al (2010) Long-term patient satisfaction with different middle ear hearing implants in sensorineural hearing loss. Otol Neurotol 31:883–892

    Article  Google Scholar 

  12. Lefebvre PP, Gisbert J, Cuda D et al (2017) A retrospective multicentre cohort review of patient characteristics and surgical aspects versus the long-term outcomes for recipients of a fully implantable active middle ear implant. Audiol Neurootol 21:333–345

    Article  Google Scholar 

  13. Jenkins HA, Pergola N, Kasic J (2007) Intra-operative ossicular loading with the Otologics fully implantable hearing device. Acta Otolaryngol 127:360–364

    Article  Google Scholar 

  14. Debeaupte M, Decullier E, Tringali S et al (2015) Evolution of the reliability of the fully implantable middle ear transducer over successive generations. Otol Neurotol 36:625–630

    Article  Google Scholar 

  15. Klein K, Nardelli A, Stafinski T (2012) A systematic review of the safety and effectiveness of fully implantable middle ear hearing devices: the carina and esteem systems. Otol Neurotol 33:916–992

    PubMed  Google Scholar 

Download references

Funding

No financial disclosures to declare.

Author information

Authors and Affiliations

  1. Auditory Implant Unit, Department of Otorhinolaryngology, Hospital CUF Porto, Porto, Portugal

    Maria da Conceição Peixoto, Cristina Miranda, Mafalda Bento, Susana Oliveira, Rui Pratas & Victor Correia da Silva

  2. Serviço de Otorrinolaringologia-Hospital Cuf Porto, Estrada da Circunvalação 14341, 4100-180, Porto, Portugal

    Maria da Conceição Peixoto

Authors
  1. Maria da Conceição Peixoto
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Cristina Miranda
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Mafalda Bento
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Susana Oliveira
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. Rui Pratas
    View author publications

    You can also search for this author in PubMed Google Scholar

  6. Victor Correia da Silva
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Maria da Conceição Peixoto.

Ethics declarations

Conflict of interest

The authors declare that they have no conflict of interest.

Additional information

Publisher's Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Peixoto, M.d., Miranda, C., Bento, M. et al. The first results of a totally implanted active middle ear device. Eur Arch Otorhinolaryngol 276, 2775–2781 (2019). https://doi.org/10.1007/s00405-019-05557-8

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s00405-019-05557-8

Keywords

Search

Navigation