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A bone conduction implant using self-drilling screws

Self-drilling screws as a new fixation method of an active transcutaneous bone conduction hearing implant

Knochenleitungsimplantat mit selbstbohrenden Schrauben

Neue Methode der Fixation eines aktiven transkutanen Knochenleitungshörimplantats

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Abstract

Background

The active transcutaneous bone conduction implant (tBCI; BONEBRIDGE™ BCI 601; MED-EL, Innsbruck, Austria) is fixed to the skull with two self-tapping screws in predrilled screw channels. The aim of this prospective study was to evaluate the safety and effectiveness of fixation with self-drilling screws instead of the self-tapping screws, in order to simplify the surgical procedure.

Materials and methods

Nine patients (mean age 37 ± 16 years, range 14–57 years) were examined pre- and 12 months postoperatively for word recognition scores (WRS) at 65 dB SPL, sound-field (SF) thresholds, bone conduction thresholds (BC), health-related quality of life (Assessment of Quality of Life, AQOL-8D questionnaire), and adverse events (AE).

Results

Due to avoidance of one surgical step, the surgical technique was simplified. Mean WRS in SF was 11.1 ± 22.2% (range 0–55%) pre- and 77.2 ± 19.9% (range 30–95%) postoperatively; mean SF threshold (pure tone audiometry, PTA4) improved from 61.2 ± 14.3 dB HL (range 37.0–75.3 dB HL) to 31.9 ± 7.2 dB HL (range 22.8–45.0 dB HL); mean BC thresholds were constant at 16.7 ± 6.8 dB HL (range 6.3–27.5 dB HL) pre- and 14.2 ± 6.2 dB HL (range 5.8–23.8 dB HL) postoperatively. AQOL-8D mean utility score increased from 0.65 ± 0.18 preoperatively to 0.82 ± 0.17 postoperatively. No device-related adverse events occurred.

Conclusion

Implant fixation by means of self-drilling screws was safe and effective in all nine patients. There was significant audiological benefit 12 months after implantation.

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Funding

The supplement containing this article is not sponsored by industry.

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Authors and Affiliations

  1. Klinik für Hals‑, Nasen‑, Ohrenkrankheiten, Plastische Operationen, Klinikum Stuttgart—Olgahospital, Kriegsbergstraße 62, 70174, Stuttgart, Germany

    Assen Koitschev

  2. Klinik für Hals‑, Nasen‑, Ohrenkrankheiten, Plastische Operationen, Universitätsklinikum Carl Gustav Carus an der TU Dresden, Dresden, Germany

    Marcus Neudert

  3. Klinik für Hals‑, Nasen‑, Ohrenkrankheiten, Plastische Operationen, Medizinische Hochschule Hannover, Hannover, Germany

    Thomas Lenarz

Authors
  1. Assen Koitschev
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  2. Marcus Neudert
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  3. Thomas Lenarz
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Corresponding author

Correspondence to Assen Koitschev.

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Conflict of interest

A. Koitschev, M. Neudert and T. Lenarz declare that they have no competing interests. The participating clinics and principal investigators had no financial or professional relationship with the sponsor that could have influenced the study. MED-EL (Innsbruck, Austria) sponsored the study (Ethics Committee fees, study conducting fees, travel expenses for the patients). Aylin Zengin and Noelani Peet (both MED-EL) edited a version of the manuscript.

For this article no studies with human participants or animals were performed by any of the authors. All studies mentioned were in accordance with the ethical standards indicated in each case.

Additional information

The German version of this article can be found under https://doi.org/10.1007/s00106-023-01294-x

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Koitschev, A., Neudert, M. & Lenarz, T. A bone conduction implant using self-drilling screws. HNO 71 (Suppl 1), 61–66 (2023). https://doi.org/10.1007/s00106-023-01295-w

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