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

August 26, 2025 updated by: Cochlear

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • Palo Alto, California, United States, 94304
        • Recruiting
        • Stanford University
        • Principal Investigator:
          • Jennifer C Alyono, MD
    • Colorado
      • Englewood, Colorado, United States, 80113
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Recruiting
        • University of Iowa
        • Contact:
    • New York
      • New York, New York, United States, 10003
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27517
        • Recruiting
        • University of North Carolina
        • Contact:
        • Principal Investigator:
          • Kevin Brown, MD
    • Ohio
      • Columbus, Ohio, United States, 43205
        • Withdrawn
        • Nationwide Children's Hospital
    • Texas
      • Dallas, Texas, United States, 75390
        • Withdrawn
        • University of Texas Southwestern Medical Center- Department of Otolaryngology Head and Neck Surgery
    • Washington
      • Seattle, Washington, United States, 98101

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Children and adults with unilateral hearing loss/single-sided deafness
Device: The Cochlear™ Nucleus® Cochlear Implant (CI) System

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®.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: pre-implantation, 12 months post-activation
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.
Time Frame: 36 months post-activation
36 months post-activation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in participant reported spatial hearing at 12 months post-activation compared to pre-operative ratings.
Time Frame: pre-implantation, 12 months post-activation
Assessed via Speech, Spatial, and Qualities of Hearing Scale (SSQ) questionnaire (parent or participant version dependent on age). Rating ranges from 0 (no ability) to 10 (complete ability). Higher scores indicate greater perceived abilities.
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.
Time Frame: pre-implantation, 12 months post-activation
Measured via the Consonant-Nucleus-Consonant (CNC) Word Recognition Test. The score is the total number of words correct expressed as percent correct (range of 0-100); higher score is better.
pre-implantation, 12 months post-activation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cochlear

Collaborators

NAMSA

Investigators

  • Study Director: Jillian Crosson, Cochlear

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 19, 2022

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

March 17, 2022

First Submitted That Met QC Criteria

March 31, 2022

First Posted (Actual)

April 8, 2022

Study Record Updates

Last Update Posted (Estimated)

September 2, 2025

Last Update Submitted That Met QC Criteria

August 26, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAM5816

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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