Mixed Hearing LossNCT05000931
Osia 2 Pediatric Expansion Study
A study testing Osia 2 System in people with Mixed Hearing Loss and Single-Sided Deafness, run by Cochlear at 7 sites in United States.
Trial 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older who present with conductive or mixed hearing loss (up to 55 dB HL) or single-sided-deafness (SSD).Published and unpublished data suggest significant pre to postoperative… Read more about this study
- Who is it for?
- Ages 5 to 11 years
- Conditions the study is for
- Mixed Hearing Loss, Single-Sided Deafness, Conductive Hearing Loss
- What is being tested?
- Osia 2 System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 7 sitesUnited States
- Study dates
- 26 Jan 2022to 14 Mar 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Subjects aged 5 to 11 years of age with the following audiometric criterion:
- 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).
- Prior experience with amplified sound through properly fitted amplification device such as a hearing aid, a CROS device, or a bone conduction device on a softband or sound arc.
- Parent or legal guardian who is willing and able to provide written informed consent for the study participant.
- Note: Subjects may include individuals seeking new implantation unilaterally (in one ear) or individuals already implanted with a bone-anchored device seeking a second-side implant (sequential bilateral)
Who cannot join
- Insufficient bone quality or quantity to support implantation of both the BI300 Implant and the OSI200 Implant.
- Chronic or non-revisable vestibular or balance disorders that could prevent benefit from the device, as determined by the investigator.
- Abnormally progressive hearing loss.
- Evidence that hearing loss is bilateral retro cochlear or bilateral central origin.
- Evidence of conditions that would prevent speech recognition improvement as determined by the investigator.
- Skin or scalp conditions that may preclude attachment of the Sound Processor or that may interfere with the use of the Sound Processor.
Show all 11Show fewer
- 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 or contractors engaged by Cochlear for the purposes of this investigation.
- Currently participating, or participated within the last 30 days, in another clinical investigation involving an investigational drug or device that could impact the safety or effectiveness of the Osia 2 system as determined by the investigator.
- Individuals undergoing simultaneous single-stage aural atresia or microtia repair due to the increased risk of skin complications associated with ear reconstruction.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
Texas Children's Hospital
Houston, Texas, 77030
Children's Minnesota
Minneapolis, Minnesota, 55404
Stanford University
Palo Alto, California, 94304
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Barrow Neurological Institute
Phoenix, Arizona, 85013
Rady Children's Hospital
San Diego, California, 92123
About this study
Official title: A Pivotal, Prospective, Multi-center, Open-label Study Evaluating the Safety and Effectiveness of the CochlearTM Osia® 2 System in a Pediatric Population.
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.
Read the detailed description
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. Due to the success of the Osia 2 system in the United States within the currently indicated patient population, clinical providers have since requested the ability to use the Osia 2 system in children aged 11 years and younger who meet the audiometric requirements. As the Osia 2 system is based on existing bone conduction and cochlear implant technologies which each possess a younger age of implantation requirement (5 years for bone conduction and 9 months for cochlear implantation), the current proposal is to align the age at implantation requirement with existing surgical bone conduction technology such as the Baha Connect and Baha Attract Systems to 5 years of age. Therefore, 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.
- Being tested
- Osia 2 System
- Medical subject headings
- Hearing Loss, Mixed Conductive-Sensorineural, Hearing Loss, Conductive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Osia 2 SystemDevice
Osia 2 System in a pediatric population aged 5 - 11 years by quantifying the type, frequency and severity of adverse events.
| Study group | Role | What they receive |
|---|---|---|
| To demonstrate the safety of the Osia 2 System in a pediatric population aged 5 - 11 years. | Experimental | Not described Receives: Device: Osia 2 System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Adverse Events Quantified by Type and Severity Between Implantation and 6-months Post-surgery.
Adverse events were reported from the time of implantation through 6-months.
Measured: From implantation to 6 months post-surgery
Secondary outcomes (4)
Change From Baseline to 6-months Post-surgery in SSQ (Speech, Spatial and Qualities of Hearing Scale) Parent Questionnaire
Measuring change of speech, spatial, quality and conversational uses of hearing (27 items in 4 sections). Each item is scored by the parent on a scale of 0 to 10 where 0 corresponds to "not at all" and 10 to "perfectly" when rating their child's ability to hear and listen in everyday situations. The score of a participant is determined as the mean of the scores for the 4 different sections. Higher scores indicate less hearing disability.
Measured: Baseline before surgery, 6 months post-surgery
Change From Baseline to 4-weeks Post-surgery in Unaided Bone Conduction Thresholds.
The Pure Tone Average (PTA) is calculated as an average of the bone conduction thresholds collected at 500, 1000, 2000, and 4000 Hz. This measure was collected unaided both pre- and post-operatively to ensure no shift in bone conduction hearing as a result of the surgery.
Measured: Baseline before surgery, 4 weeks post-surgery
Change in Word Recognition Using Consonant Nucleus Consonant (CNC) Words Presented in Quiet From Unaided Baseline to Aided 6-months Post-surgery.
The CNC Words test consists of 10 recorded lists of 50 monosyllabic words. For this study, one list is administered per test condition at 60 dBA in sound field and scored as the number of phonemes and words correct, which will be expressed as a percentage correct when analyzed. The CNC word test has a score range of 0-100% with higher values indicating better scores.
Measured: Baseline before surgery, 6 months post-surgery
Change in Sentence Recognition in Noise Using the Bramford Kowal Bench Speech-In-Noise (BKB-SIN) From Unaided Baseline to Aided 6-months Post-surgery.
The Bamford-Kowal-Bench Sentence in Noise test (BKB-SIN) consists of 36 paired lists. 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.
Measured: Baseline before surgery, 6 months post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2021
- Study start26 Jan 2022
- Primary completion22 Sep 2023
- Study completion14 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mixed Hearing LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cochlear
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- R. P. Chiacchierini Consulting, LLC, Analytic Solutions Group
- Responsible party
- Sponsor
- Investigators
- Lori O'Neill, Study director, Cochlear
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05000931
- Sponsor's protocol ID
- CAM 5766
- Status last verified
- Nov 2024
- First submitted
- 23 Jul 2021
- Last updated
- 11 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: 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.
Publications
Stevens SM, Meyer A, Rivas A, Mowry S, Carvalho D, Chang KW, Germiller J, Liu YC, Tejani V. Outcomes Following Cochlear Osia 2 Implantation in Patients Ages 5-11 Years: A Multi-Center Trial. Laryngoscope. 2025 Aug;135(8):2958-2966. doi: 10.1002/lary.32159. Epub 2025 Apr 11.
PubMed 40214186
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pivotal, Prospective, Multi-center, Open-label Study Evaluating the Safety and Effectiveness of the CochlearTM Osia® 2 System in a Pediatric Population.
- ClinicalTrials.gov ID
- NCT05000931
- Acronym / sponsor ID
- CAM 5766
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- CochlearIndustry (pharma, biotech, devices)
- Collaborators
- R. P. Chiacchierini Consulting, LLC, Analytic Solutions Group
- Study start
- 26 Jan 2022 (actual)
- Primary completion
- 22 Sep 2023 (actual)
- Study completion
- 14 Mar 2024 (actual)
- First posted
- 11 Aug 2021 (actual)
- Results
- Posted 5 Jun 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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. Due to the success of the Osia 2 system in the United States within the currently indicated patient population, clinical providers have since requested the ability to use the Osia 2 system in children aged 11 years and younger who meet the audiometric requirements. As the Osia 2 system is based on existing bone conduction and cochlear implant technologies which each possess a younger age of implantation requirement (5 years for bone conduction and 9 months for cochlear implantation), the current proposal is to align the age at implantation requirement with existing surgical bone conduction technology such as the Baha Connect and Baha Attract Systems to 5 years of age. Therefore, 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| To demonstrate the safety of the Osia 2 System in a pediatric population aged 5 - 11 years. | Experimental | Device: Osia 2 System |
Who may qualify
- Ages
- 5 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Subjects aged 5 to 11 years of age with the following audiometric criterion:
- Prior experience with amplified sound through properly fitted amplification device such as a hearing aid, a CROS device, or a bone conduction device on a softband or sound arc.
- Parent or legal guardian who is willing and able to provide written informed consent for the study participant.
- Note: Subjects may include individuals seeking new implantation unilaterally (in one ear) or individuals already implanted with a bone-anchored device seeking a second-side implant (sequential bilateral)
Key exclusion criteria (11 listed)
- Insufficient bone quality or quantity to support implantation of both the BI300 Implant and the OSI200 Implant.
- Chronic or non-revisable vestibular or balance disorders that could prevent benefit from the device, as determined by the investigator.
- Abnormally progressive hearing loss.
- Evidence that hearing loss is bilateral retro cochlear or bilateral central origin.
- Evidence of conditions that would prevent speech recognition improvement as determined by the investigator.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Osia 2 SystemOsia 2 System in a pediatric population aged 5 - 11 years by quantifying the type, frequency and severity of adverse events. | Device | To demonstrate the safety of the Osia 2 System in a pediatric population aged 5 - 11 years. |
Primary outcome
Number of Adverse Events Quantified by Type and Severity Between Implantation and 6-months Post-surgery.
Time frame: From implantation to 6 months post-surgery
Adverse events were reported from the time of implantation through 6-months.
4 secondary outcomes
Change From Baseline to 6-months Post-surgery in SSQ (Speech, Spatial and Qualities of Hearing Scale) Parent Questionnaire
Time frame: Baseline before surgery, 6 months post-surgery
Change From Baseline to 4-weeks Post-surgery in Unaided Bone Conduction Thresholds.
Time frame: Baseline before surgery, 4 weeks post-surgery
Change in Word Recognition Using Consonant Nucleus Consonant (CNC) Words Presented in Quiet From Unaided Baseline to Aided 6-months Post-surgery.
Time frame: Baseline before surgery, 6 months post-surgery
Change in Sentence Recognition in Noise Using the Bramford Kowal Bench Speech-In-Noise (BKB-SIN) From Unaided Baseline to Aided 6-months Post-surgery.
Time frame: Baseline before surgery, 6 months post-surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40214186Stevens SM, Meyer A, Rivas A, Mowry S, Carvalho D, Chang KW, Germiller J, Liu YC, Tejani V. Outcomes Following Cochlear Osia 2 Implantation in Patients Ages 5-11 Years: A Multi-Center Trial. Laryngoscope. 2025 Aug;135(8):2958-2966. doi: 10.1002/lary.32159. Epub 2025 Apr 11.
- Individual participant dataSharing planned: No. 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.
Related trials for Mixed Hearing Loss
RecruitingObservational study
Pilot Study to Evaluate the Long-term Chronic Care of Patients Who Could or do Utilize an Osseointegrated Device (OID)
Hearing Loss, Conductive, Hearing Loss, Mixed
Recruiting
Post-market Evaluation of the Transition From the Baha Connect System to the Osia System in Adult Bone Conduction Implant Recipients
Bone Conduction, Hearing Loss, Conductive
Active, not recruiting
Expanded Indications in the Pediatric BONEBRIDGE Population
Hearing Loss, Conductive, Hearing Loss, Mixed
Active, not recruiting
Pediatric Expansion Study of the Sentio System
Hearing Loss, Conductive, Hearing Loss, Mixed
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Comparative Study of Non-surgical Hearing Devices Based on Bone Conduction
Mixed Hearing Loss, Conductive Hearing Loss
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lori O'Neill study director
Cochlear
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Osia 2 System in people with Mixed Hearing Loss and Single-Sided Deafness, run by Cochlear at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Adverse Events Quantified by Type and Severity Between Implantation and 6-months Post-surgery. (time frame: From implantation to 6 months post-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05000931, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2024.