Clinical Investigation of New CI Delivery Models in an Adult Nucleus CI Population

Cochlear

Status: Completed

Conditions: Cochlear Implant; Sensorineural Hearing Loss, Bilateral

Treatments: Device: Commercially available cochlear implant and AI system

Study type: Interventional

Funder types: Industry

Identifiers

NCT03304106

CAM 5417

Details and patient eligibility

About

Use of Artificial Intelligent (AI) technology to assist audiologists in programming cochlear implants.

Enrollment: 102 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Newly implanted and existing recipient Groups (Groups 1 and 2):

• Age 12 and older
• Monosyllabic word score administered at 60dBA (2 lists) with an appropriately fit hearing aid in the ear to be implanted who are receiving a cochlear implant as standard of care
• Group 2: 3 months or greater combined experience with commercially available sound processors
• Fluent spoken English skills

Exclusion criteria

• Unrealistic expectations on the part of the subject regarding the possible benefits, risks, and limitations
• Additional cognitive, medical or social handicaps that would prevent completion of all study requirements as determined by the Investigational team
• Unwillingness or inability of the subject to comply with all investigational requirements
• Use of an acoustic component in the implanted ear
• Less than 18 active electrodes
• Hybrid L Cochlear Implant

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

102 participants in 2 patient groups

Newly Implanted CI Recipients

Experimental group

Description:

Use of AI technology to assist in audiologist's evaluation and programming of new (standard of care-commercial) cochlear implant recipients

Treatment:

Device: Commercially available cochlear implant and AI system

Existing CI recipients

Experimental group

Description:

Use of AI technology to assist in audiologist's evaluation and programming of existing cochlear implant recipients

Treatment:

Device: Commercially available cochlear implant and AI system