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

A Post-approval, Prospective, Nonrandomized, Single-arm Multicenter Investigation to Evaluate the Safety and Effectiveness of Cochlear Implantation in Children and Adults With Unilateral Hearing Loss/Single-sided Deafness

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.

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.