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Osia 2 Pediatric Expansion Study

NCT05000931 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2024-12-11

Study results available
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Summary

The CochlearTM Osia®2 System was cleared by the Food and Drug Administration November 15, 2019 (K191921) for individuals aged 12 years and older who present with conductive or mixed hearing loss (up to 55 dB HL) or single-sided-deafness (SSD).Published and unpublished data suggest significant pre to postoperative benefit and minimal risk in both children and adults who have received the Osia system. Thus the objective of this study is to examine the safety and effectiveness of the Cochlear Osia 2 system in a group of pediatric subjects aged 5 to 11 years who suffer from conductive or mixed hearing loss (up to 55 dB HL), or single-sided-deafness (SSD) with the intent of expanding the indications for use.

Conditions

  • Mixed Hearing Loss
  • Single-Sided Deafness
  • Conductive Hearing Loss

Interventions

DEVICE

Osia 2 System

Osia 2 System in a pediatric population aged 5 - 11 years by quantifying the type, frequency and severity of adverse events.

Sponsors & Collaborators

  • R. P. Chiacchierini Consulting, LLC

    collaborator INDUSTRY

  • Analytical Solutions Group, Inc.

    collaborator UNKNOWN

  • Cochlear

    lead INDUSTRY

Principal Investigators

  • Lori O'Neill · Cochlear

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
5 Years
Max Age
11 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-26
Primary Completion
2023-09-22
Completion
2024-03-14
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05000931 on ClinicalTrials.gov