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European Archives of Oto-Rhino-Laryngology

, Volume 274, Issue 8, pp 3011–3019 | Cite as

A multicenter study on objective and subjective benefits with a transcutaneous bone-anchored hearing aid device: first Nordic results

  • Dan Dupont HougaardEmail author
  • Soren Kjaergaard Boldsen
  • Anne Marie Jensen
  • Soren Hansen
  • Per Cayé Thomassen
Otology

Abstract

Examination of objective as well as subjective outcomes with a new transcutaneous bone-anchored hearing aid device. The study was designed as a prospective multicenter consecutive case-series study involving tertiary referral centers at two Danish University Hospitals. A total of 23 patients were implanted. Three were lost to follow-up. Patients had single-sided deafness, conductive or mixed hearing loss. Intervention: Rehabilitative. Aided and unaided sound field hearing was evaluated objectively using (1) pure warble tone thresholds, (2) pure-tone average (PTA4), (3) speech discrimination score (SDS) in quiet, and (4) speech reception threshold 50% at 70 dB SPL noise level (SRT50%). Subjective benefit was evaluated by three validated questionnaires: (1) the IOI-HA, (2) the SSQ-12, and (3) a questionnaire evaluating both the frequency and the duration of hearing aid usage. The mean aided PTA4 was lowered by 14.7 dB. SDS was increased by 37.5% at 50 dB SPL, SRT50% in noise improved 1.4 dB. Aided thresholds improved insignificantly at frequencies above 2 kHz. 52.9% of the patients used their device every day, and 76.5% used the device at least 5 days a week. Mean IOI-HA score was 3.4, corresponding to a good benefit. In SSQ-12, “quality of hearing” scored especially high. Patients with a conductive and/or mixed hearing loss benefitted the most. This device demonstrates a significant subjective hearing benefit 8 month post surgery. In patients with conductive and/or mixed hearing losses, patient satisfaction and frequency of use were high. Objective gain measures showed less promising results especially in patients with single-sided deafness (SSD) compared to other bone conduction devices.

Keywords

Bone-anchored hearing device BAHA attract Transcutaneous Bone-anchored hearing aid Hearing loss Bone conduction 

Notes

Compliance with ethical standards

Conflict of interest

No organization has sponsored this research. The Danish distributor of Cochlear products, Danaflex, has granted funding for the transportation of nine patients from one region of the country to another region to have the audiological testing done at the Audiological Department at Copenhagen University Hospital. The funding has been equal to the cost of a return train ticket from one part of the country to the other. The audiological testing could only take place at one facility due to the extent of advanced equipment required. A total amount of approximately 1500 USD was granted for this purpose.

Ethical approval

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

Informed consent

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

References

  1. 1.
    Tjellström A, Lindström J, Hallén O et al (1981) Osseointegrated titanium implants in the temporal bone. A clinical study on bone-anchored hearing aids. Am J Otol 2:304–310PubMedGoogle Scholar
  2. 2.
    Snik AF, Mylanus EA, Proops DW et al (2005) Consensus statements on the BAHA system: where do we stand at present? Ann Otol Rhinol Laryngol Suppl 195:2–12CrossRefPubMedGoogle Scholar
  3. 3.
    Dun CA, Faber HT, de Wolf MJ, Cremers CW, Hol MK (2011) An overview of different systems: the bone-anchored hearing aid. Adv Otorhinolaryngol 71:22–31PubMedGoogle Scholar
  4. 4.
    Hakansson B, Tjellström A, Rosenhall U, Carlsson P (1985) The bone-anchored hearing aid. Principal design and a psychoacoustical evaluation. Acta Otolaryngol 100(3–4):229–239CrossRefPubMedGoogle Scholar
  5. 5.
    Kiringoda R, Lustig LR (2013) A meta-analysis of the complications associated with osseointegrated hearing aids. Otol Neurotol 34:790–794CrossRefPubMedGoogle Scholar
  6. 6.
    Holgers KM, Tjellström A, Bjursten LM, Erlandsson BE et al (1988) Soft tissue reactions around percutaneous implants: a clinical study of soft tissue conditions around skin-penetrating titanium implants for bone anchored hearing aids. Am J Otol 9:56–59PubMedGoogle Scholar
  7. 7.
    Reyes RA, Tjellstöm A, Granström G (2000) Evaluation of implant losses and skin reactions around extraoral bone-anchored implants: a 0-to 8-year follow-up. Otolaryngol Head Neck Surg 122:272–276CrossRefPubMedGoogle Scholar
  8. 8.
    Hobson JC, Roper AJ, Andrew R, Rothera MP, Hill P, Green KM (2010) Complications of bone-anchored hearing aid implantation. J Laryngol Otol 124:132–136CrossRefPubMedGoogle Scholar
  9. 9.
    Calvo Bodnia N, Foghsgaard S, Nue Moller M, Cayé-Thomasen P (2014) Long-term results of 185 consecutive osseointegrated hearing device implantations: a comparison among children, adults, and elderly. Otol Neurotol 35:e301–e306CrossRefPubMedGoogle Scholar
  10. 10.
    Kurz A, Flynn M, Caversaccio M, Kompis M (2014) Speech understanding with a new implant technology: a comparative study with a new Nonskin penetrating BAHA system. Biomed Res Int 2014:416205CrossRefPubMedPubMedCentralGoogle Scholar
  11. 11.
    Elberling C, Ludvigsen C, Lyregaard PE (1989) DANTALE: a new Danish speech material. Scand Audiol 18(3):169–175CrossRefPubMedGoogle Scholar
  12. 12.
    Cox RM, Alexander GC (2002) The international outcome inventory for hearing aids (IOI-HA): psychometric properties of the English version. Int J Audiol 41(1):30–35CrossRefPubMedGoogle Scholar
  13. 13.
    Thunberg Jespersen C, Bille M, Legarth JV (2014) Psychometric properties of a revised Danish translation of the international outcome inventory for hearing aids (IOI-HA). Int J Audiol 53(5):302–308CrossRefPubMedPubMedCentralGoogle Scholar
  14. 14.
    Noble W, Jensen NS, Naylor G, Bhullar N, Akeroyd MA (2013) A short form of the speech, spatial and qualities of hearing scale suitable for clinical use: the SSQ12. Int J Audiol 52(6):409–412CrossRefPubMedGoogle Scholar
  15. 15.
    Rasmussen J, Olsen SO, Nielsen LH (2012) Evaluation of long-term patient satisfaction and experience with the Baha(R) bone conduction implant. Int J Audiol 51(3):194–199CrossRefPubMedGoogle Scholar
  16. 16.
    Briggs R, Van Hasselt A, Luntz Michal et al (2015) Clinical performance of a new magnetic bone conduction hearing implant system: results from a prospective, multicenter, clinical investigation. Otol Neurotol 36:834–841CrossRefPubMedGoogle Scholar
  17. 17.
    Denoyelle F, Leboulanger N, Coudert C, Mazzaschi O et al (2013) New closed skin bone-anchored implant: preliminary results in 6 children with ear Atresia. Otol Neurotol 34:275–281CrossRefPubMedGoogle Scholar
  18. 18.
    Eberhard KE, Olsen SØ, Miyazaki H, Bille M, Caye-Thomasen P (2016) Objective and subjective outcome of a new transcutaneous bone conduction hearing device: half-year follow-up of the first 12 nordic implantations. Otol Neurotol 37(3):267–275. doi: 10.1097/MAO.0000000000000969 PubMedGoogle Scholar
  19. 19.
    Cox RM, Stephens D, Kramer SE (2002) Translations of the international outcome inventory for hearing aids (IOI-HA). Int J Audiol 41(1):3–26CrossRefPubMedGoogle Scholar
  20. 20.
    Tjellstrom A, Hakansson B, Granstrom G (2001) Bone-anchored hearing aids: current status in adults and children. Otolaryngol Clin N Am 34(2):337–364CrossRefGoogle Scholar
  21. 21.
    Verstraeten N, Zarowski AJ, Somers T, Riff D, Offeciers EF (2009) Comparison of the audiologic results obtained with the bone anchored hearing aid attached to the headband, the test band, and to the ‘‘snap’’ abutment. Otol Neurotol 30:70–75CrossRefPubMedGoogle Scholar
  22. 22.
    Gerdes T, Salcher RB, Schwab B, Lenarz T et al (2016) Comparison of audiological results between a transcutaneous and a percutaneous bone conduction instrument in conductive hearing loss. Otol Neurotol 27:685–691CrossRefGoogle Scholar
  23. 23.
    Powell HRF, Rolfe AM, Birman CS (2015) A comparative study of audiologic outcomes for two transcutaneous bone-anchored hearing devices. Otol Neurotol 36:1525–1531CrossRefPubMedGoogle Scholar
  24. 24.
    Riss D, Arnoldner C, Baumgartner WD, Blineder M et al (2014) Indication criteria and outcomes with the bonebridge transcutaneous bone-conduction implant. Laryngoscope 124:2802–2806CrossRefPubMedGoogle Scholar
  25. 25.
    Nadaraja GS, Gurgel RK, KiM J, Chang KW (2013) Hearing outcomes of atresia surgery versus osseointegrated bone conduction device in patients with congenital aural atresia: a systematic review. Otol Neurotol 34(8):1394–1399CrossRefPubMedGoogle Scholar
  26. 26.
    Gawecki W, Stieler OM, Balcerowiak A et al. (2016) Surgical, functional and audiological evaluation of new BAHA attract system implantations. Eur Arch Otorhinolaryngol 273(10):3123–3130CrossRefPubMedPubMedCentralGoogle Scholar
  27. 27.
    Carr D, Moraleda J, Procter V, Wright K, Ray J (2015) Initial UK experience with a novel transcutaneous bone conduction device. Otol Neurotol 36:1399–1402CrossRefPubMedGoogle Scholar
  28. 28.
    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 16:12CrossRefPubMedPubMedCentralGoogle Scholar
  29. 29.
    Hakansson BE, Carlsson PU, Tjellstrom A, Liden G (1994) The bone-anchored hearing aid: principal design and audiometric results. Ear Nose Throat J 73(9):670–675PubMedGoogle Scholar
  30. 30.
    Gurgel RK, Jackler RK, Dobie RA, Popelka GR (2012) A new standardized format for reporting hearing outcome in clinical trials. Otolaryngol Head Neck Surg 147(5):803–807CrossRefPubMedGoogle Scholar

Copyright information

© Springer-Verlag Berlin Heidelberg 2017

Authors and Affiliations

  • Dan Dupont Hougaard
    • 1
    Email author
  • Soren Kjaergaard Boldsen
    • 2
  • Anne Marie Jensen
    • 3
  • Soren Hansen
    • 4
  • Per Cayé Thomassen
    • 4
  1. 1.Department of Otolaryngology, Head and Neck Surgery and AudiologyAalborg University HospitalAalborgDenmark
  2. 2.Unit of Clinical Biostatistics and BioinformaticsAalborg University HospitalAalborgDenmark
  3. 3.Department of AudiologyCopenhagen University HospitalRigshospitaletDenmark
  4. 4.Department of Otolaryngology, Head and Neck SurgeryCopenhagen University HospitalRigshospitaletDenmark

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