Recruiting

Robotics & ECochG

Sponsor:

iotaMotion, Inc.

Code:

NCT06664710

Conditions

Hearing Loss, Sensorineural

Cochlear Implantation

Eligibility Criteria

Sex: All

Age: 12+

Healthy Volunteers: Not accepted

Interventions

iotaSOFT Insertion System with AIM

iotaSOFT Insertion System with AIM Control

Study Details

Brief summary:

Evaluation of the Automated Integration of a Robotics and ECochG System for Use with Cochlear Implant Surgery

Conditions

Hearing Loss, Sensorineural

Cochlear Implantation

Study ID

NCT06664710

Start date

Jan 17, 2024

Status verified date

Jan, 2025

Completion date

Aug 30, 2025

Anticipated

Primary completion date

Aug 30, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Cochlear implant candidate in one or two ears per current FDA indications
2. Sufficient residual hearing to support use of electrocochleography, as determined by the investigator
3. Cochlear implantation using the Advanced Bionics SlimJ electrode array
4. 18 years of age or older at the time of enrollment
5. Willingness to participate in and comply with all requirements of the protocol

Exclusion Criteria:

Contraindications for a CI. 2. Prior cochlear implantation in the ear to be implanted. 3. Cochlear ossification or malformation (including but not limited to dysplasia or common cavity), craniofacial abnormality or any other structural cochlear abnormality that might prevent complete insertion of the electrode array or present an increased risk of aberrant insertion.

4. History of temporal bone fracture that involves the cochlea/internal auditory canal.

5. Retrocochlear etiology (e.g. diagnosis of auditory neuropathy, cochlear nerve deficiency, or lesions of the acoustic nerve or central auditory pathway).

6. Active middle-ear infection or tympanic membrane perforation in the presence of active middle ear disease.

7. Planned or current participation in a clinical study of an investigational device or drug that may impact data collection or outcomes related to this investigation.

8. Additional medical concerns that would prevent participation in evaluations as determined by the investigator.

9. Unrealistic expectations on the part of the subject, regarding the possible benefits, risks, and limitations that are inherent to the procedure and investigational device.

10. Vulnerable subject, as per FDA regulations 21 CFR Parts 50 and 56

Study Design

Enrollment

10 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Device Feasibility

Interventions and Outcome Measures

Arms

active comparator: Control

Use of the iotaSOFT Insertion System and AIM based on Standard of Care

experimental: Experimental

Use of iotaSOFT Insertion System with AIM experimental device

Interventions

iotaSOFT Insertion System with AIM

Experimental subjects will receive the iotaSOFT Insertion System with AIM using robotic controlled stop

iotaSOFT Insertion System with AIM Control

iotaSOFT Insertion System with AIM using standard of care insertion techniques

Primary outcome measure

  • Device Feasibility [ Time Frame: Procedure Day 0 ]

Central Contacts and Locations

Central contacts

Laura Chenier, Director of Clinical Affairs, AuD

442-325-4171lchenier@iotamotion.com

Locations

University of Iowa

Recruiting

Iowa City, Iowa, United States, 52242

More Information

Sponsor

iotaMotion, Inc.

Last update posted

May 1, 2025

Last verified

Jan, 2025

Keywords

  • cochlear implantation
  • sensorineural hearing loss
  • robotics

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by iotaMotion, Inc. on 2025-05-01.