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
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
Wazen JJ, Spitzer JB, Ghossaini SN et al (2003) Transcranial contralateral cochlear stimulation in unilateral deafness. Otolaryngol Head Neck Surg 129(3):248–254
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
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
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
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
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
CochlearTM BAHA attract system. https://www.cochlear.com/wps/wcm/connect/uk/home/discover/baha-boneconductionimplants/baha-attract-system. Accessed 18 July 2019.
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.
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
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
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
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
Zernotti ME, Sarasty AB (2015) Active bone conduction prosthesis: bonebridge(TM). Int Arch Otorhinolaryngol 19(4):343–348
Cochlear.com Osia® Implant. https://www.cochlear.com/us/en/home/products-and-accessories/cochlear-osia-system/osia-implant Accessed 9 Apr 2020
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
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
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
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
Robinson K, Gatehouse S, Browning GG (1996) Measuring patient benefit from otorhinolaryngological surgery and therapy. Ann Otol Rhinol Laryngol 105:415–422
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
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
Weinstein BE (2015) Outcome measurement in audiology: a call to action. Hearing J 68(7):24–26
Denniston AK, Kyte D, Calvert M et al (2014) An introduction to patient reported outcome measures in ophthalmic research. Eye (Lond) 28:637–645
Bianchin G, Bonali M, Russo M, Tribi L (2015) Active bone conduction system: outcomes with the Bonebridge transcutaneous device. ORL 77(1):17–26
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
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
McCulloch P, Altman DG, Campbell WB et al (2009) No surgical innovation without evaluation: the IDEAL recommendations. Lancet 374:1105–1112
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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