🏛️ Verified NIH Protocol • Sourced via U.S. National Library of Medicine (Last Synced: 2025-09-02)

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

🟢 Recruiting Protocol / Phase N/A ⚙️ Medical Device Protocol Sponsor: Cochlear

🩺 Protocol 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.

Primary Research Facility: Stanford University (Palo Alto, California)

📋 Basic Study Criteria & Logistics Checklist

0 of 3 Checked

Review these 3 basic logistical and protocol criteria extracted from the public NIH record. (This is a preliminary logistical checklist, not an official clinical eligibility determination).

Diagnosed with, undergoing evaluation for, or seeking treatment related to Hearing Loss, Unilateral?

🔍 Study Population / Focus Area (Source: Protocol Primary Condition)

Aged 5 Years or older?

🔍 Protocol Specified Minimum Age: 5 Years

Able to attend required in-person clinic visits and study procedures at one of the participating study centers?

🔍 Logistical Requirement: 8 Registered Participating Sites

📍 Primary Site Map

Site: Stanford University — Palo Alto, California

📍 All Participating Trial Locations (8 Sites)

Multi-Center Trial

This protocol is enrolling participants across multiple clinical centers:

1. Stanford University — Palo Alto, California

2. Rocky Mountain Ear Center — Englewood, Colorado • Contact: (303) 806-6293

3. University of Iowa — Iowa City, Iowa • Contact: (319) 353-8776

4. New York Eye and Ear Infirmary — New York, New York • Contact: (929) 489-9611

5. University of North Carolina — Chapel Hill, North Carolina • Contact: (919) 966-5251

6. Nationwide Children's Hospital — Columbus, Ohio

7. University of Texas Southwestern Medical Center- Department of Otolaryngology Head and Neck Surgery — Dallas, Texas

8. Virginia Mason Medical Center — Seattle, Washington • Contact: (206) 287-6267

📄 Print Doctor Discussion Sheet

Preview and print a 1-page summary with 5 tailored questions for your physician.

💰 Clinical Trial Costs & Insurance Coverage

Coverage for clinical trial participation varies depending on your health insurance policy, state legislation, and whether specific procedures are investigational research or routine medical care. Under federal law (Affordable Care Act § 2709), health insurers generally cannot drop coverage or refuse to pay for routine patient care costs incurred in approved clinical trials.

💡 Always ask the study coordinator for the trial's official Informed Consent Form, which outlines all sponsor-funded research items versus procedures billed to your insurance.

🏛️ Official Government Provenance

NIH ClinicalTrials.gov Protocol Record

NCT Identifier: NCT05318417 • Last Synced: 2025-09-02

View on ClinicalTrials.gov ↗