Investigation to Evaluate the Safety and Effectiveness of Cochlear Implantation in Children and Adults With Unilateral Hearing Loss/Single-sided Deafness
Trial ID or NCT#
NCT05318417
Status
NOT RECRUITING
Purpose
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.
Official Title
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
Eligibility Criteria
Ages Eligible for Study: Older than 5 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
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.
Investigator(s)
Jennifer Alyono, MD MS
Otology and neurotology specialist,
Medical Otologist
Clinical Assistant Professor, Otolaryngology (Head and Neck Surgery)
View on ClinicalTrials.gov
