Investigation to Evaluate the Safety and Effectiveness of Cochlear Implantation in Children and Adults With Unilateral Hearing Loss/Single-sided Deafness (PAS-SSD)

Cochlear

Status

Enrolling

Conditions

Deafness, Unilateral

Hearing Loss, Unilateral

Treatments

Device: The Cochlear™ Nucleus® Cochlear Implant (CI) System

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT05318417

CAM5816

Details and patient eligibility

About

The aim of the study is to assess the continued efficacy and safety of cochlear implantation in participants aged 5 years and above with Unilateral Hearing Loss (UHL)/Single Sided Deafness (SSD) supporting a change indication for use.

Enrollment

60 estimated patients

Sex

All

Ages

5+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

• Individuals 18 years or older (Group A)

Ear to be Implanted:

Severe sensorineural hearing loss (HL) defined as: Pure-tone average at 0.5, 1, 2, 4 kHz >80 dB HL ; Aided Consonant-Nucleus-Consonant Test (CNC) score ≤5% and

Normal Hearing Ear:

Normal or near normal hearing defined as an average of (0.5, 1, 2, 4kHz) ≤ 30 dB HL

• Children 5 years to 17 years, 11 months (Group B)

Ear to be Implanted:

Severe sensorineural HL defined as: Pure-tone average at 0.5, 1, 2, 4 kHz >80 dB HL; Aided CNC score ≤5% and

Normal Hearing Ear:

Normal or near normal hearing defined as an average of (0.5, 1, 2, 4kHz) ≤ 30 dB HL

Previous experience with a current conventional treatment option for unilateral [SSD] HL (HA, bone-conduction device, or CROS technology), if no previous experience a minimum trial period of two weeks is required
English spoken as a primary language
Willing and able to provide written informed consent

Exclusion criteria

Ossification, abnormal cochlear nerve or any other cochlear anomaly that might prevent complete insertion of the electrode array
Previous cochlear implantation
Hearing loss of neural or central origin, including auditory neuropathy
Duration of profound sensorineural HL >10 years per self-report
Active / chronic middle-ear infection; conductive HL in either ear
Medical or psychological conditions that contraindicate undergoing surgery as determined by the Investigator
Unrealistic expectations on the part of the participant/family, regarding the possible benefits, risks, and limitations that are inherent as determined by the Investigator
Evidence of and/or suspected cognitive or developmental concern
Unable or unwilling to comply with the requirements of the clinical investigation as determined by the Investigator
Investigator site personnel directly affiliated with this study and/or their immediate families; immediate family is defined as a spouse, parent, child or sibling
Cochlear employees or employees of Contract Research Organizations (CROs) or contractors engaged by Cochlear for the purposes of this investigation
Pregnant or breastfeeding women
Currently participating, or participated within the last 30 days, in another interventional clinical investigation/trial involving an investigational drug or device.