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Audiological outcomes of robot-assisted cochlear implant surgery

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

Abstract

Purpose

The main objective of this study is to evaluate the short-term and long-term audiological outcomes in patients who underwent cochlear implantation with a robot-assisted system to enable access to the cochlea, and to compare outcomes with a matched control group of patients who underwent cochlear implantation with conventional access to the cochlea.

Methods

In total, 23 patients were implanted by robot-assisted cochlear implant surgery (RACIS). To evaluate the effectiveness of robotic surgery in terms of audiological outcomes, a statistically balanced control group of conventionally implanted patients was created. Minimal outcome measures (MOM), consisting of pure-tone audiometry, speech understanding in quiet and speech understanding in noise were performed pre-operatively and at 3 months, 6 months, 12 months and 2 years post-activation of the audioprocessor.

Results

There was no statistically significant difference in pure-tone audiometry, speech perception in quiet and speech perception in noise between robotically implanted and conventionally implanted patients pre-operatively, 3 months, 6 months, 12 months and 2 years post-activation. A significant improvement in pure-tone hearing thresholds, speech understanding in quiet and speech understanding in noise with the cochlear implant has been quantified as of the first measurements at 3 months and this significant improvement remained stable over a time period of 2 years for HEARO implanted patients.

Conclusion

Clinical outcomes in robot-assisted cochlear implant surgery are comparable to conventional cochlear implantation.

Clinicaltrails.gov trail registration numbers

NCT03746613 (date of registration: 19/11/2018), NCT04102215 (date of registration: 25/09/2019).

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Data availability

The datasets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.

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Funding

The Antwerp University Hospital and University Hospital Brussels are currently receiving a research grant from MED-EL (Innsbruck, Austria). VT holds a national Fonds Wetenschappelijk Onderzoek Fundamenteel Klinisch Mandaat (FWO FKM) senior researcher grant [Grant number 18B3222N]. The authors received no specific financial support for the research, authorship, and/or publication of this article.

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Authors and Affiliations

  1. Department of Otorhinolaryngology Head and Neck Surgery, University Hospital Brussels, Vrije Universiteit Brussel, Brussels Health Campus, Brussels, Belgium

    Emilie Heuninck & Vedat Topsakal

  2. Department of Otorhinolaryngology, Head and Neck Surgery, Antwerp University Hospital, Antwerp, Belgium

    Paul Van de Heyning, Vincent Van Rompaey & Griet Mertens

  3. Experimental Laboratory of Translational Neurosciences and Dento-Otolaryngology, Faculty of Medicine and Health Sciences, University of Antwerp, Antwerp, Belgium

    Paul Van de Heyning, Vincent Van Rompaey & Griet Mertens

Authors
  1. Emilie Heuninck
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  2. Paul Van de Heyning
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  3. Vincent Van Rompaey
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  4. Griet Mertens
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  5. Vedat Topsakal
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Contributions

VT and PH contributed to the conception and design of the study. VV and GM were involved in inclusion and postoperative evaluation of participants. EH analyzed data and wrote the first draft of the manuscript. VT, PH, VV and GM critically revised the manuscript. All authors read and approved the submitted version of the manuscript.

Corresponding author

Correspondence to Emilie Heuninck.

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Conflict of interest

The authors declare that there is no conflict of interest.

Ethics approval

The EAR2OS study was registered at clinical trials.gov under identifier NCT03746613 and HEARO device exemption number 80M0763 from the Federal Agency for Medicines and Health Products (FAMHP). The approval of the Antwerp University Hospital ethics committee was granted with number B300201837507. A follow-up study (ARCI25) was registered at clinicaltrails.gov under identifier NCT04102215. The approval of the Antwerp University Hospital ethics committee was granted with number B300201941457 and HEARO device exemption 80M0793.

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All participants gave written informed consent prior to participation in accordance with the Declaration of Helsinki.

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Heuninck, E., Van de Heyning, P., Van Rompaey, V. et al. Audiological outcomes of robot-assisted cochlear implant surgery. Eur Arch Otorhinolaryngol 280, 4433–4444 (2023). https://doi.org/10.1007/s00405-023-07961-7

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  • DOI: https://doi.org/10.1007/s00405-023-07961-7

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