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

Not Applicable

Not yet recruiting

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

• Registration Number: NCT07081542
• Lead Sponsor: AdventHealth

Brief 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. 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-30
• Study First Submitted QC: 2025-07-15
• Last Update Submitted: 2025-07-15
• Study First Posted: 2025-07-23
• Last Update Posted: 2025-07-23
• Study Start: 2025-07-30
• Primary Completion: 2027-01-31
• Study Completion: 2027-01-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 32

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in Low-Frequency Pure Tone Average (LFPTA)	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.
Speech Recognition Using CNC Word Test	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.
Speech Recognition Using AzBio Sentence Test	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.
Degree of Low-Frequency Hearing Preservation	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 Outcome Measures

Name	Time	Method
Impedance Measurements	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.

Trial Locations

Locations (1)

AdventHealth Celebration; 🇺🇸 Kissimmee, Florida, United States