Evaluation of the Automated Integration of a Robotics and ECochG System for Use With Cochlear Implant Surgery (AIMBOT)

iotaMotion

Status: Enrolling

Conditions: Cochlear Implantation; Hearing Loss, Sensorineural

Treatments: Device: iotaSOFT Insertion System with AIM; Device: iotaSOFT Insertion System with AIM Control

Study type: Interventional

Funder types: Industry

Identifiers

NCT06664710

IAR2401

Details and patient eligibility

About

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

Full description

The purpose of this study is to evaluate the feasibility and proof of concept of the integration of the AIM System and iotaSOFT Insertion System during cochlear implantation. Study results will help inform the need for future clinical investigations and data collection in the area of ECochG and robotic-assisted cochlear implantation.

Enrollment: 10 estimated patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Device Feasibility

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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10 participants in 2 patient groups

Control

Active Comparator group

Description:

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

Treatment:

Device: iotaSOFT Insertion System with AIM Control

Experimental

Experimental group

Description:

Use of iotaSOFT Insertion System with AIM experimental device

Treatment:

Device: iotaSOFT Insertion System with AIM