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Bone Conduction Hearing Device

Osia 2 System for Pediatric Hearing Loss

N/A
Waitlist Available
Research Sponsored by Cochlear
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
A conductive or mixed hearing loss and still can benefit from sound amplification. The pure tone average (PTA) bone conduction (BC) threshold (measured at 0.5, 1, 2, and 3 kHz) should be better than or equal to 55 dB HL. OR A profound sensorineural hearing loss in one ear and normal hearing in the opposite ear (i.e., single-sided deafness or "SSD"). The pure tone average air conduction hearing thresholds of the hearing ear should be better than or equal to 20 dB HL (measured at 0.5, 1, 2, and 3 kHz).
Subjects aged 5 to 11 years with profound sensorineural hearing loss in one ear and normal hearing in the opposite ear (single-sided deafness or 'SSD') with PTA air conduction hearing thresholds better than or equal to 20 dB HL at 0.5, 1, 2, and 3 kHz
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months post-surgery
Awards & highlights

Study Summary

This trial is testing the safety and effectiveness of the Cochlear Osia 2 system in children aged 5 to 11 years who suffer from conductive or mixed hearing loss (up to 55 dB HL), or single-sided-deafness (SSD).

Who is the study for?
This trial is for children aged 5 to 11 with conductive or mixed hearing loss, or single-sided deafness (SSD), who may benefit from the Osia 2 System. Candidates should have a certain level of bone conduction threshold and normal hearing in one ear if SSD. They must have experience with hearing devices and be able to comply with study requirements.Check my eligibility
What is being tested?
The safety and effectiveness of the Cochlear Osia 2 system are being tested in young children to potentially expand its use. The device, which was previously approved for individuals over age 12, helps those with specific types of hearing loss hear better.See study design
What are the potential side effects?
While not explicitly stated here, side effects could include discomfort at the implant site, skin irritation around the processor attachment area, or issues related to sound quality and perception.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have hearing loss but can still benefit from a hearing aid, or I am deaf in one ear but the other ear hears well.
Select...
I am aged 5-11 with severe hearing loss in one ear and normal hearing in the other.
Select...
I am aged 5-11 with hearing loss that improves with sound amplification.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months post-surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months post-surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of adverse events quantified by type, frequency, and severity between surgery and 6-months post-surgery.
Secondary outcome measures
Change from baseline to 4-weeks post-surgery in unaided bone conduction thresholds.
Change from baseline to 6-month post-surgery in parental questionnaires.
Change in sentence recognition in noise using the BKB-SIN from baseline to 6-months post-surgery.
+1 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: To demonstrate the safety of the Osia 2 System in a pediatric population aged 5 - 11 years.Experimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Osia 2 System
2022
N/A
~70

Find a Location

Who is running the clinical trial?

Analytical Solutions Group, Inc.UNKNOWN
2 Previous Clinical Trials
1,640 Total Patients Enrolled
R. P. Chiacchierini Consulting, LLCUNKNOWN
2 Previous Clinical Trials
1,640 Total Patients Enrolled
NAMSAOTHER
45 Previous Clinical Trials
16,873 Total Patients Enrolled

Media Library

Osia 2 System (Bone Conduction Hearing Device) Clinical Trial Eligibility Overview. Trial Name: NCT05000931 — N/A
Conductive Hearing Loss Research Study Groups: To demonstrate the safety of the Osia 2 System in a pediatric population aged 5 - 11 years.
Conductive Hearing Loss Clinical Trial 2023: Osia 2 System Highlights & Side Effects. Trial Name: NCT05000931 — N/A
Osia 2 System (Bone Conduction Hearing Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05000931 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What type of participants are most ideal for this research trial?

"This medical experiment is currently recruiting fifty minors aged from five to eleven with a combined hearing loss. Candidates must meet the following criteria: they can be new recipients of an implant, or seeking their second-side implant; prior experience using proper amplification devices such as CROS device, bone conduction device on sound arc; and either have a conductive/mixed hearing loss with PTA BC threshold less than 55 dB HL OR profound sensorineural hearing loss in one ear plus normal hearing capability in another (SSD); lastly, air conduction thresholds must also be lower than 20 dB HL at 0.5 - 3 kHz frequencies"

Answered by AI

Is recruitment ongoing for this clinical research?

"Affirmative. Clinicaltrials.gov connotes that this clinical trial is actively looking for participants, which first posted on January 26th 2022 and was last updated October 5th 2022. Fifty people are necessary to be enrolled from 7 distinct medical centres."

Answered by AI

How widely dispersed are the facilities offering this research endeavor?

"The research team is seeking participants from 11 clinical trial sites, including Barrow Neurological Institute in Phoenix, Arizona; Rady Children's Hospital in San Diego, California; and the renowned Children's Hospital of Philadelphia located in Pennsylvania."

Answered by AI

What is the approximate number of participants involved in this research endeavor?

"This trial necessitates 50 participants with the specified qualifications, and can be undertaken at Barrow Neurological Institute in Phoenix or Rady Children's Hospital in San Diego."

Answered by AI

Are minors included in the parameters of this experiment?

"According to the enrollment criteria, this medical trial is only open for participants between 5 and 11 years of age."

Answered by AI

Who else is applying?

What state do they live in?
Nevada
North Carolina
How old are they?
18 - 65
< 18
What site did they apply to?
Rady Children's Hospital
Children's Hospital of Philadelphia
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria

How responsive is this trial?

Typically responds via
Email
Most responsive sites:
  1. Children's Hospital of Philadelphia: < 48 hours
Average response time
  • < 2 Days
Recent research and studies
clinicaltrials.govStudy
Osia 2 Pediatric Expansion Study
2022. "Osia 2 Pediatric Expansion Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05000931.
~15 spots leftby Apr 2025
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