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Robot vs. surgeon: which cochlear implant method gives better hearing?

NCT ID NCT07081542

Symptom relief Sponsor: AdventHealth Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study compares two ways to insert a cochlear implant: using a robotic device or the standard manual method. Researchers want to see which approach leads to better hearing one year after surgery. The study will enroll 32 adults with hearing loss, randomly assigning them to one of the two techniques. Both methods are already approved and considered safe.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
IotaSoft Robotic Insertion System
What this could lead to
If robotic insertion proves better, it could become the new standard for cochlear implants, potentially improving hearing outcomes and reducing inner ear damage.
What could go wrong
This is a small early-stage study with only 32 participants, so results may not apply to everyone. The robotic device is already FDA-approved, but the study may find no significant difference between methods.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 32 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jan 2026

An estimate. Start dates often move.

Expected to finish

Jan 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Deafness hearing disorder hearing loss disorder Hearing Loss, Bilateral Hearing Loss, Sensorineural inner ear disorder sensorineural hearing loss disorder vestibular disorder X-linked mixed hearing loss with perilymphatic gusher

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Bilateral hearing loss Cochlear implantation Hearing disorders Hearing disorders and deafness Hearing impairment Inner ear disorders Sensorineural hearing loss

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • AdventHealth Celebration

    Kissimmee, Florida, 34747, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.