The iotaSOFT Insertion System Safety Study

iotaMotion

Status: Completed

Conditions: Cochlear Implant

Treatments: Device: iotaSOFT Insertion System

Study type: Interventional

Funder types: Industry

Identifiers

NCT04577118

iotaSOFT000001

Details and patient eligibility

About

Non-significant risk evaluation of the iotaSOFT Insertion System when used by a surgeon to assist with inserting a cochlear implant electrode array.

Full description

This is a confirmatory study to assess successful peri-procedural use of the iotaSOFT Insertion System and potential adverse events that may be caused by use of the system during cochlear implant surgery.

Enrollment: 25 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Candidate for cochlear implantation per indications
• Age 18 years or older

Key Exclusion Criteria:

• Prior cochlear implantation in ear to be treated
• Ossification or any other cochlear anomaly that might prevent complete insertion of the electrode ray
• Craniofacial abnormality or abnormal cochlear/nerve anatomy on pre-operative CT or MR imaging
• Deafness due to lesions of the acoustic nerve or central auditory pathway
• Diagnosis of auditory neuropathy
• Active middle ear infection

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

iotaSOFT Insertion System

Other group

Description:

The iotaSOFT Insertion System is a surgical device that aids the surgeon in implanting cochlear electrode arrays by controlling the speed and distance of implant insertion. All subjects enrolled in the trial will have the iotaSOFT Insertion System used during surgery.

Treatment:

Device: iotaSOFT Insertion System