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.
Cochlear implant candidates >18 years of age
LFPTA (125Hz, 250Hz, 500Hz) <80dB
Pediatric patients (below the age of 18)
LFPTA (125Hz, 250Hz, 500Hz) >80dB
Revision cases
Severe comorbidities that contraindicate surgery.
Parallel
IotaSoft Robotic Insertion System
DeviceThe 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
Procedure/SurgeryStandard surgical technique for manually inserting the cochlear implant electrode array. This method reflects the current standard of care without the assistance of robotic tools.
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.
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.
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.
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)
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.
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This trial is not recruiting at the moment. You can still explore other options:
