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

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.