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First United Kingdom experience of the novel Osia active transcutaneous piezoelectric bone conduction implant

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

Abstract

Purpose

Bone conduction hearing devices are widely used and indicated in cases of conductive, mixed or single-sided deafness where the conventional hearing aids are not indicated or tolerated. This prospective study aims to investigate the surgical and hearing outcomes of a novel active piezoelectric transcutaneous bone conduction device (t-BCD).

Methods

Prospective data were collected from the first 10 patients who underwent implantation with the t-BCD Osia (Cochlear, Australia) (between Dec 2018 and March 2019) in a tertiary referral centre. The main outcome measures include: surgical outcome, free field speech testing with speech recognition thresholds, audiological gain and patient-reported outcomes including the ‘Glasgow Benefit Inventory’ (GBI) and the ‘Client Oriented Scale of Improvement (COSI).

Results

The mean length of surgery was 70.6 min (range 50–87, SD = 9.5). Mean skin thickness measured was 5.6 mm (range 4–8, SD = 1.1). There were two post-operative wound infections which settled conservatively. One required revision surgery to thin skin. The average gain in hearing with the implant was + 39.4 dB. Pre-implantation mean unaided SRT was 38.1 dB (SD = 7.8) and the post-implantation mean-aided SRT was 22.7 dB (SD = 4.6) (p = 0.000078). There was improvement in COSI domains. The mean Glasgow disability score dropped from 52% pre-implantation to 20% post-implantation (p = 0.001).

Conclusions

This new active t-BCHD provides excellent audiological gain and improvement in speech recognition. Patient-reported outcomes have also been very positive. The surgery was straightforward with no major surgical complications reported. Further studies will be required to examine long-term outcomes in larger number of patients.

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References

  1. de Wolf MJ, Hendrix S, Cremers CW, Snik AF (2011) Better performance with bone-anchored hearing aid than acoustic devices in patients with severe air-bone gap. Laryngoscope 121(3):613–616

    Article  Google Scholar 

  2. Wazen JJ, Spitzer JB, Ghossaini SN et al (2003) Transcranial contralateral cochlear stimulation in unilateral deafness. Otolaryngol Head Neck Surg 129(3):248–254

    Article  Google Scholar 

  3. Kim G, Ju HM, Lee SH, Kim HS, Kwon JA, Seo YJ (2017) Efficacy of bone-anchored hearing aids in single-sided deafness: a systematic review. Otol Neurotol 38(4):473–483

    Article  CAS  Google Scholar 

  4. Shapiro S, Ramadan J, Cassis A (2018) BAHA skin complications in the pediatric population: systematic review with meta-analysis. Otol Neurotol 39(7):865–873

    Article  Google Scholar 

  5. Steehler MW, Larner SP, Mintz JS, Steehler MK, Lipman SP, Griffith S (2018) A comparison of the operative techniques and the postoperative complications for bone-anchored hearing aid implantation. Int Arch Otorhinolaryngol 22(4):368–373

    Article  Google Scholar 

  6. Gluth MB, Eager KM, Eikelboom RH, Atlas MD (2010) Long-term benefit perception, complications, and device malfunction rate of bone-anchored hearing aid implantation for profound unilateral sensorineural hearing loss. Otol Neurotol 31(9):1427–1434

    PubMed  Google Scholar 

  7. Briggs R, Van Hasselt A, Luntz M et al (2015) Clinical performance of a new magnetic bone conduction hearing implant system: results from a prospective, multicenter, clinical investigation. Otol Neurotol 36(5):834–841

    Article  Google Scholar 

  8. CochlearTM BAHA attract system. https://www.cochlear.com/wps/wcm/connect/uk/home/discover/baha-boneconductionimplants/baha-attract-system. Accessed 18 July 2019.

  9. MED-EL active vs. passive transcutaneous bone conduction systems. https://www.medel.com/int/show/index/id/1495/title/Active-vs--Passive/. Accessed 2018 July 2019.

  10. Riss D, Arnoldner C, Baumgartner WE et al (2014) Indication criteria and outcomes with the bonebridge transcutaneous bone-conduction implant. Laryngoscope 124(12):2802–2806

    Article  Google Scholar 

  11. Sprinzl G, Wolf-Magele A (2016) The bonebridge bone conduction hearing implant: indication criteria, surgery and a systematic review of the literature. Clin Otolaryngol 41(2):131–143

    Article  CAS  Google Scholar 

  12. Rahne T, Seiwerth I, Götze G et al (2015) Functional results after bonebridge implantation in adults and children with conductive and mixed hearing loss. Eur Arch Otorhinolaryngol 272(11):3263–3269

    Article  Google Scholar 

  13. Weiss R, Leinung M, Baumann U, Weißgerber T, Rader T, Stöver T (2017) Improvement of speech perception in quiet and in noise without decreasing localization abilities with the bone conduction device bonebridge. Eur Arch Otorhinolaryngol 274(5):2107–2115

    Article  Google Scholar 

  14. Zernotti ME, Sarasty AB (2015) Active bone conduction prosthesis: bonebridge(TM). Int Arch Otorhinolaryngol 19(4):343–348

    Article  Google Scholar 

  15. Cochlear.com Osia® Implant. https://www.cochlear.com/us/en/home/products-and-accessories/cochlear-osia-system/osia-implant Accessed 9 Apr 2020

  16. Goycoolea M, Ribalta G, Tocornal F et al (2020) Clinical performance of the Osia™ system, a new active osseointegrated implant system. Results of a prospective clinical investigation. Acta Otolaryngol 140(3):212–219

    Article  Google Scholar 

  17. McCulloch P, Cook JA, Altman DG, Heneghan C, Diener MK (2013) IDEAL Group. IDEAL framework for surgical innovation 1: the idea and development stages. BMJ 346:f3012

    Article  Google Scholar 

  18. Sedrakyan A, Campbell B, Merino JG, Kuntz R, Hirst A, McCulloch P (2016) IDEAL-D: a rational framework for evaluating and regulating the use of medical devices. BMJ 353:i2372

    Article  Google Scholar 

  19. Agha RA, Fowler AJ, Rajmohan S, Barai I, Orgill DP (2016) PROCESS group. Preferred reporting of case series in surgery: the PROCESS guidelines. Int J Surg 36:319–323

    Article  Google Scholar 

  20. Robinson K, Gatehouse S, Browning GG (1996) Measuring patient benefit from otorhinolaryngological surgery and therapy. Ann Otol Rhinol Laryngol 105:415–422

    Article  CAS  Google Scholar 

  21. Dillon H, James A, Ginis J (1997) Client oriented scale of improvement (COSI) and its relationship to several other measures of benefit and satisfaction provided by hearing aids. J Am Acad Audiol 8:27–43

    PubMed  CAS  Google Scholar 

  22. Magele A, Schoerg P, Stanek B, Gradl B, Sprinzl GM (2019) Active transcutaneous bone conduction hearing implants: systematic review and meta-analysis. PLoS ONE 14(9):e0221484

    Article  CAS  Google Scholar 

  23. Weinstein BE (2015) Outcome measurement in audiology: a call to action. Hearing J 68(7):24–26

    Article  Google Scholar 

  24. Denniston AK, Kyte D, Calvert M et al (2014) An introduction to patient reported outcome measures in ophthalmic research. Eye (Lond) 28:637–645

    Article  CAS  Google Scholar 

  25. Bianchin G, Bonali M, Russo M, Tribi L (2015) Active bone conduction system: outcomes with the Bonebridge transcutaneous device. ORL 77(1):17–26

    Article  CAS  Google Scholar 

  26. Monini S, Bianchi A, Talamonti R, Atturo F, Filippi C, Barbara M (2017) Patient satisfaction after auditory implant surgery: ten-year experience from a single implanting unit center. Acta Otolaryngol 137(4):389–397

    Article  Google Scholar 

  27. Dimitriadis PA, Farr MR, Allam A, Ray J (2016) Three year experience with the cochlear BAHA attract implant: a systematic review of the literature. BMC Ear Nose Throat Disord 16:12

    Article  Google Scholar 

  28. McCulloch P, Altman DG, Campbell WB et al (2009) No surgical innovation without evaluation: the IDEAL recommendations. Lancet 374:1105–1112

    Article  Google Scholar 

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Correspondence to Kimberley Lau.

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All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards.

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Informed consent was obtained from all individual participants included in the study.

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Lau, K., Scotta, G., Wright, K. et al. First United Kingdom experience of the novel Osia active transcutaneous piezoelectric bone conduction implant. Eur Arch Otorhinolaryngol 277, 2995–3002 (2020). https://doi.org/10.1007/s00405-020-06022-7

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  • DOI: https://doi.org/10.1007/s00405-020-06022-7

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