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NCT Number: NCT07081542

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

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.

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Key information

Conditions

Sensorineural Hearing Loss Bilateral Hearing Loss Cochlear Implantation Deafness Ear Diseases Hearing Disorders Hearing Disorders and Deafness Hearing Impairment Hearing Loss Hearing Loss, Bilateral Hearing Loss, Sensorineural Inner Ear Disorders Labyrinth Diseases Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms Vestibular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Change in Low-Frequency Pure Tone Average (LFPTA)

    Time frame: Baseline (pre-op) to 12 months post-activation

    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.

  2. Speech Recognition Using CNC Word Test

    Time frame: 3, 6, and 12 months post-activation

    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. Speech Recognition Using AzBio Sentence Test

    Time frame: 3, 6, and 12 months post-activation

    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.

  4. Degree of Low-Frequency Hearing Preservation

    Time frame: Baseline to 12 months post-activation

    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)

Secondary outcomes

  1. Impedance Measurements

    Time frame: CI activation (6-8 weeks post-op)

    To assess device function and consistency over time by measuring electrical impedance (in kilo-ohms, kΩ) of cochlear implant electrodes following either robotic or manual insertion. Impedance will be recorded at activation. Lower and more stable impedance values are expected to indicate better electrode-tissue interface and improved device function. The hypothesis is that robotic cochlear implantation will result in lower and more consistent impedance values compared to manual insertion.

Study contacts

Contact information is provided by the study sponsor or research team.

Bridget Clinical Research Operations Manager, MS, MPH

CONTACT

[email protected]

407-303-5503

Petronio Senior Clinical Research Operations Manager, MHA

CONTACT

[email protected]

407-303-5503

Sponsors and collaborators

Lead sponsor

AdventHealth

Other

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 23, 2025
Registry last updated
Jan 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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