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

AdventHealth

Status: Not yet enrolling

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

Treatments: Procedure: Manual Cochlear Implant Insertion; Device: IotaSoft Robotic Insertion System

Study type: Interventional

Funder types: Other

Identifiers

NCT07081542

2269273

Details and patient eligibility

About

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.

Enrollment: 32 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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32 participants in 2 patient groups

Robotic-Assisted Cochlear Implant Insertion

Experimental group

Description:

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

Treatment:

Device: IotaSoft Robotic Insertion System

Manual Cochlear Implant Insertion

Active Comparator group

Description:

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

Treatment:

Procedure: Manual Cochlear Implant Insertion