Osia 2 Pediatric Expansion Study

NCT05000931 | Completed Results DMC FDA Device

• 1 other identifier: CAM 5766
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 7

Brief 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older who present with conductive or mixed hearing loss (up to 55 dB HL) or single-sided-deafness (SSD).Published and unpublished data suggest significant pre to postoperative benefit and minimal risk in both children and adults who have received the Osia system.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

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  Baseline before surgery, 6 months post-surgery

• Change From Baseline to 4-weeks Post-surgery in Unaided Bone Conduction Thresholds.

  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.

  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.

  Baseline before surgery, 6 months post-surgery

Study Arms (1)

To demonstrate the safety of the Osia 2 System in a pediatric population aged 5 - 11 years.

EXPERIMENTAL

Device: Osia 2 System

Interventions

Osia 2 System DEVICE

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

To demonstrate the safety of the Osia 2 System in a pediatric population aged 5 - 11 years.

Eligibility Criteria

• Age: 5 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Cochlear: lead
• R. P. Chiacchierini Consulting, LLC: collaborator
• Analytical Solutions Group, Inc.: collaborator

Study Sites (7)

Barrow Neurological Institute

Phoenix, Arizona, 85013, United States

Location

Stanford University

Palo Alto, California, 94304, United States

Location

Rady Children's Hospital

San Diego, California, 92123, United States

Location

Children's Minnesota

Minneapolis, Minnesota, 55404, United States

Location

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Texas Children's Hospital

Houston, Texas, 77030, United States

Location

Related Publications (1)

• 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.

  PMID: 40214186 DERIVED

MeSH Terms

Conditions

Hearing Loss, Mixed Conductive-Sensorineural; Hearing Loss, Conductive

Condition Hierarchy (Ancestors)

Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: PRS Specialist, Clinical Affairs
• Organization: Cochlear

cltd-prs-admin@cochlear.com

+61 2 9428 6555

Study Officials

• Lori O'Neill

  Cochlear

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2021
• First Posted: August 11, 2021
• Study Start: January 26, 2022
• Primary Completion: September 22, 2023
• Study Completion: March 14, 2024
• Last Updated: December 11, 2024
• Results First Posted: June 5, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)