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Not yet recruiting NCT07081542

Comparative Analysis of Hearing Outcomes: Robotic vs. Manual Insertion of Cochlear Implants

No phase Interventional Sensorineural Hearing Loss Bilateral Hearing Loss Cochlear Implantation Hearing Disorders

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: IotaSoft Robotic Insertion System, Manual Cochlear Implant Insertion.
Who it may be relevant to
Registry conditions: Sensorineural Hearing Loss, Bilateral Hearing Loss, Cochlear Implantation, Hearing Disorders. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

This research study is evaluating two different methods of cochlear implant (CI) insertion - robotic-assisted insertion and manual insertion - to better understand how they affect hearing outcomes. Participants in this study will be randomly assigned to receive their cochlear implant using one of these two techniques. Both methods are performed in a standard operating room by qualified surgeons, and both are considered safe and approved for use. The main goal is to compare how well participants hear one year after surgery based on the insertion method used. The study will also look at things like surgical time, inner ear health, and how the hearing nerve responds. All participants will receive the same type of cochlear implant device and follow-up care. This study may help guide future surgical techniques and improve outcomes for individuals receiving cochlear implants.

Interventions

  • Device IotaSoft Robotic Insertion System
    The IotaSoft robotic insertion device is an FDA-approved tool designed to provide precise and controlled insertion of the cochlear implant electrode array to minimize trauma during implantation.
  • Procedure Manual Cochlear Implant Insertion
    Standard surgical technique for manually inserting the cochlear implant electrode array. This method reflects the current standard of care without the assistance of robotic tools.

Primary outcome measures

  • Change in Low-Frequency Pure Tone Average (LFPTA) [Time frame: Baseline (pre-op) to 12 months post-activation]
  • Speech Recognition Using CNC Word Test [Time frame: 3, 6, and 12 months post-activation]
  • Speech Recognition Using AzBio Sentence Test [Time frame: 3, 6, and 12 months post-activation]
  • Degree of Low-Frequency Hearing Preservation [Time frame: Baseline to 12 months post-activation]
Secondary outcome measures (1)
  • Impedance Measurements [Time frame: CI activation (6-8 weeks post-op)]

Eligibility criteria

Inclusion criteria

  • Cochlear implant candidates >18 years of age
  • LFPTA (125Hz, 250Hz, 500Hz) <80dB

Exclusion criteria

  • Pediatric patients (below the age of 18)
  • LFPTA (125Hz, 250Hz, 500Hz) >80dB
  • Revision cases
  • Severe comorbidities that contraindicate surgery.
  • Preexisting cochlear anomalies.
  • Do not speak English or Spanish

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • AdventHealth Celebration — Kissimmee

Publications

  • Barriat S, Peigneux N, Duran U, Camby S, Lefebvre PP. The Use of a Robot to Insert an Electrode Array of Cochlear Implants in the Cochlea: A Feasibility Study and Preliminary Results. Audiol Neurootol. 2021;26(5):361-367. doi: 10.1159/000513509. Epub 2021 Apr 26. PMID 33902040
  • Gersdorff G, Peigneux N, Duran U, Camby S, Lefebvre PP. Impedance and Functional Outcomes in Robotic-Assisted or Manual Cochlear Implantation: A Comparative Study. Audiol Neurootol. 2025;30(1):80-88. doi: 10.1159/000540577. Epub 2024 Aug 23. PMID 39182488
  • Heuninck E, Van de Heyning P, Van Rompaey V, Mertens G, Topsakal V. Audiological outcomes of robot-assisted cochlear implant surgery. Eur Arch Otorhinolaryngol. 2023 Oct;280(10):4433-4444. doi: 10.1007/s00405-023-07961-7. Epub 2023 Apr 12. PMID 37043021
  • Maheo C, Marie A, Torres R, Archutick J, Leclere JC, Marianowski R. Robot-Assisted and Manual Cochlear Implantation: An Intra-Individual Study of Speech Recognition. J Clin Med. 2023 Oct 17;12(20):6580. doi: 10.3390/jcm12206580. PMID 37892718
  • Caversaccio M, Gavaghan K, Wimmer W, Williamson T, Anso J, Mantokoudis G, Gerber N, Rathgeb C, Feldmann A, Wagner F, Scheidegger O, Kompis M, Weisstanner C, Zoka-Assadi M, Roesler K, Anschuetz L, Huth M, Weber S. Robotic cochlear implantation: surgical procedure and first clinical experience. Acta Otolaryngol. 2017 Apr;137(4):447-454. doi: 10.1080/00016489.2017.1278573. Epub 2017 Feb 1. PMID 28145157

Identifiers

NCT: NCT07081542 · 2269273

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗