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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-01

Study Completion Date

2027-01-31

Brief Summary

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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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Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Robotic-Assisted Cochlear Implant Insertion

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

Group Type EXPERIMENTAL

IotaSoft Robotic Insertion System

Intervention Type 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

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

Group Type ACTIVE_COMPARATOR

Manual Cochlear Implant Insertion

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

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.

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No