Investigation to Evaluate the Safety and Effectiveness of Cochlear Implantation in Children and Adults With Unilateral Hearing Loss/Single-sided Deafness
PAS-SSD
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
1 other identifier
interventional
60
1 country
8
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2022
Longer than P75 for not_applicable
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 17, 2022
CompletedFirst Posted
Study publicly available on registry
April 8, 2022
CompletedStudy Start
First participant enrolled
August 19, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2027
September 2, 2025
May 1, 2025
4.7 years
March 17, 2022
August 26, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Change in sentence in noise scores at 12 months post-activation in the binaural (CI and normal hearing (NH)) listening condition compared to preoperatively in the best listening (NH alone or NH and hearing aid) condition in 3 speaker configurations.
Measured with the Bamford-Kowal-Bench Sentence in Noise test (BKB-SIN). List of sentences are presented at 65 dBA with the level of noise varied stepwise at fixed signal to noise ratio to obtain a Speech Reception Threshold (SRT) where participants are able to repeat key words 50% of the time. Score range is not specified as metric is adaptive; lower scores indicate better performance. The 3 speaker configurations are: speech front/noise front; speech front/noise to NH ear; speech front/noise to poorer ear.
pre-implantation, 12 months post-activation
Number of procedure and device related adverse events classified by type, frequency and severity.
36 months post-activation
Secondary Outcomes (2)
Change in participant reported spatial hearing at 12 months post-activation compared to pre-operative ratings.
pre-implantation, 12 months post-activation
Change in word recognition at 12 months post-activation in the CI alone condition compared to preoperative aided condition in the poorer hearing ear alone.
pre-implantation, 12 months post-activation
Study Arms (1)
Children and adults with unilateral hearing loss/single-sided deafness
OTHERInterventions
The Cochlear™ Nucleus® CI systems are designed to provide useful hearing. The system works by converting sound in the environment into electric pulses that stimulate the auditory nerve, allowing the brain to perceive sound. The Cochlear™ Nucleus® CI system has implanted and external components. Implanted component: The CI is surgically implanted under the skin behind the ear. It includes a receiver/stimulator to receive and decode the electrical signals from the sound processor and an electrode to deliver these signals to the cochlear. External components: The external components include a sound processor, and associated accessories and cables. The system is programmed by a Cochlear proprietary programming system, Custom Sound®.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
Stanford University
Palo Alto, California, 94304, United States
Rocky Mountain Ear Center
Englewood, Colorado, 80113, United States
University of Iowa
Iowa City, Iowa, 52242, United States
New York Eye and Ear Infirmary
New York, New York, 10003, United States
University of North Carolina
Chapel Hill, North Carolina, 27517, United States
Nationwide Children's Hospital
Columbus, Ohio, 43205, United States
University of Texas Southwestern Medical Center- Department of Otolaryngology Head and Neck Surgery
Dallas, Texas, 75390, United States
Virginia Mason Medical Center
Seattle, Washington, 98101, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Jillian Crosson
Cochlear
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 17, 2022
First Posted
April 8, 2022
Study Start
August 19, 2022
Primary Completion (Estimated)
May 1, 2027
Study Completion (Estimated)
June 1, 2027
Last Updated
September 2, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will not share
Cochlear do not have an approved platform for public sharing of IPD collected in this study. Data may be provided to individual researchers on request.