Bilateral Hearing Loss, Cochlear Implantation, Hearing Disorders, Hearing Disorders and Deafness, Hearing Impairment, Inner Ear Disorders, Sensorineural Hearing Loss
Conditions
Keywords
Cochlear Implant, Robotic Cochlear Implant Insertion, Hearing Performance, Speech Perception, Electrocochleography, Hearing Rehabilitation, Postoperative Hearing Outcomes, Minimally Invasive ENT Surgery
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.
Interventions
DEVICEIotaSoft 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.
PROCEDUREManual 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.
Sponsors
AdventHealth
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Contacts
Primary ContactPetronio Senior Clinical Research Operations Manager, MHA
Backup ContactBridget Clinical Research Operations Manager, MS, MPH
Outcome results
None listed