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Sensorineural Hearing LossNCT07081542

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

A study testing IotaSoft Robotic Insertion System and Manual Cochlear Implant Insertion in people with Sensorineural Hearing Loss and Bilateral Hearing Loss, run by AdventHealth at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
IotaSoft Robotic Insertion System and Manual Cochlear Implant Insertion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
1 siteUnited States
Study dates
1 Jan 2026to 31 Jan 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

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

United States1 site

  • AdventHealth Celebration

    Kissimmee, Florida, 34747

    Petronio Martins, MHA, 407-303-5503, petronio.martins@adventhealth.com

    Bridget Miller, MS, MPH, 407-303-5503, bridget.miller@adventhealth.com

Other trials in United States

About this study

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.

Being tested
IotaSoft Robotic Insertion System, Manual Cochlear Implant Insertion
Keywords
Cochlear Implant, Robotic Cochlear Implant Insertion, Hearing Performance, Speech Perception, Electrocochleography, Hearing Rehabilitation, Postoperative Hearing Outcomes, Minimally Invasive ENT Surgery
Medical subject headings
Hearing Loss, Sensorineural, Hearing Loss, Bilateral, Hearing Disorders, Deafness, Vestibular Diseases, Hearing Loss

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IotaSoft Robotic Insertion SystemDevice

    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 InsertionProcedure or surgery

    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.

Study groups in NCT07081542
Study groupRoleWhat they receive
Robotic-Assisted Cochlear Implant InsertionExperimentalSurgical technique using robotic assistance (IotaSoft system) to perform the cochlear implant electrode array insertion into the cochlea.
Receives: Device: IotaSoft Robotic Insertion System
Manual Cochlear Implant InsertionActive comparatorStandard surgical technique for inserting the cochlear implant electrode array without robotic assistance. This represents the standard of care method.
Receives: Procedure: Manual Cochlear Implant Insertion

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. 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.

    Measured: 3, 6, and 12 months post-activation

  3. 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.

    Measured: 3, 6, and 12 months post-activation

  4. 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)

    Measured: Baseline to 12 months post-activation

Secondary outcomes (1)

  1. Impedance Measurements

    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.

    Measured: CI activation (6-8 weeks post-op)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jul 2025
  2. Study start1 Jan 2026 (estimated)
  3. Primary completion31 Jan 2027 (estimated)
  4. Study completion31 Jan 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
32 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07081542
Sponsor's protocol ID
2269273
Status last verified
May 2025
First submitted
30 May 2025
Last updated
2 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No: We will not be sharing information from this study.

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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 28145157

Questions about this trial

What is this clinical trial studying?

A study testing IotaSoft Robotic Insertion System and Manual Cochlear Implant Insertion in people with Sensorineural Hearing Loss and Bilateral Hearing Loss, run by AdventHealth at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 2 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Petronio Senior Clinical Research Operations Manager, MHA (407-303-5503, Petronio.martins@adventhealth.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Low-Frequency Pure Tone Average (LFPTA) (time frame: Baseline (pre-op) to 12 months post-activation). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07081542, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2026.

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