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

NCT07081542 | Not Yet Recruiting FDA Device

• 1 other identifier: 2269273
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hearing Impairment; Sensorineural Hearing Loss; Bilateral Hearing Loss; Cochlear Implantation; Hearing Disorders; Hearing Disorders and Deafness; Inner Ear Disorders

Keywords

Cochlear Implant; Robotic Cochlear Implant Insertion; Hearing Performance; Speech Perception; Electrocochleography; Hearing Rehabilitation; Postoperative Hearing Outcomes; Minimally Invasive ENT Surgery

Outcome Measures

Primary Outcomes (4)

• Change in Low-Frequency Pure Tone Average (LFPTA)

  Change in unaided pure tone thresholds at 125, 250, and 500 Hz from baseline to 12 months post-activation. The average of these frequencies will be computed for each participant.

  Baseline (pre-op) to 12 months post-activation

• Speech Recognition Using CNC Word Test

  Participants' ability to recognize individual spoken words will be assessed using the Consonant-Nucleus-Consonant (CNC) word test in both quiet and noise conditions. Outcome is based on the percent of key words correctly repeated.

  3, 6, and 12 months post-activation

• Speech Recognition Using AzBio Sentence Test

  Participants' ability to recognize spoken sentences will be assessed using the AzBio sentence test in quiet and noise. Outcome is based on the percent of key words correctly repeated in standardized sentence lists.

  3, 6, and 12 months post-activation

• Degree of Low-Frequency Hearing Preservation

  Subjects will be categorized based on change in LFPTA into: * Full preservation (\<15 dB loss) * Partial preservation (15-30 dB loss) * Significant loss (\>30 dB loss)

  Baseline to 12 months post-activation

Secondary Outcomes (1)

• Impedance Measurements

  CI activation (6-8 weeks post-op)

Study Arms (2)

Robotic-Assisted Cochlear Implant Insertion

EXPERIMENTAL

Surgical technique using robotic assistance (IotaSoft system) to perform the cochlear implant electrode array insertion into the cochlea.

Device: IotaSoft Robotic Insertion System

Manual Cochlear Implant Insertion

ACTIVE COMPARATOR

Standard surgical technique for inserting the cochlear implant electrode array without robotic assistance. This represents the standard of care method.

Procedure: Manual Cochlear Implant Insertion

Interventions

IotaSoft Robotic Insertion System DEVICE

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.

Robotic-Assisted Cochlear Implant Insertion

Manual Cochlear Implant Insertion PROCEDURE

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.

Manual Cochlear Implant Insertion

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• AdventHealth: lead

Study Sites (1)

AdventHealth Celebration

Kissimmee, Florida, 34747, United States

Location

Related Publications (5)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Hearing Loss, Sensorineural; Hearing Loss, Bilateral; Hearing Disorders; Deafness; Vestibular Diseases; Hearing Loss

Condition Hierarchy (Ancestors)

Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Labyrinth Diseases

Central Study Contacts

Petronio Senior Clinical Research Operations Manager, MHA

CONTACT

407-303-5503; Petronio.martins@adventhealth.com

Bridget Clinical Research Operations Manager, MS, MPH

CONTACT

407-303-5503; Bridget.Miller@adventhealth.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2025
• First Posted: July 23, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): January 31, 2027
• Last Updated: January 2, 2026

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)