An interventional study of IotaSoft Robotic Insertion System and Manual Cochlear Implant Insertion in Sensorineural Hearing Loss, Bilateral Hearing Loss and Cochlear Implantation, sponsored by AdventHealth. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-01-02.
Sponsored by AdventHealth · Not applicable, Interventional, and Treatment
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.
346 studies on the registry are indexed under Hearing Loss, Sensorineural; 100 are open to participants now.
This study's planned enrollment of 32 is close to the median of 32 across 247 interventional studies indexed under Hearing Loss, Sensorineural.
Browse Hearing Loss, Sensorineural studies →AdventHealth is the lead sponsor of 113 studies on the registry; 22 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 2 (40%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Surgical technique using robotic assistance (IotaSoft system) to perform the cochlear implant electrode array insertion into the cochlea.
Device: IotaSoft Robotic Insertion System
Standard surgical technique for inserting the cochlear implant electrode array without robotic assistance. This represents the standard of care method.
Procedure: Manual Cochlear Implant Insertion
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.
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.
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.
Time frame: Baseline (pre-op) to 12 months post-activation
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.
Time frame: 3, 6, and 12 months post-activation
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.
Time frame: 3, 6, and 12 months post-activation
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)
Time frame: Baseline to 12 months post-activation
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.
Time frame: CI activation (6-8 weeks post-op)
Plan to share: No — We will not be sharing information from this study.
This study is not yet recruiting, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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