Osia 2 Pediatric Expansion Study

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older who present with conductive or mixed hearing loss (up to 55 dB HL) or single-sided-deafness (SSD).Published and unpublished data suggest significant pre to postoperative benefit and minimal risk in both children and adults who have received the Osia system.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

Study Overview

• Status: Completed
• Conditions: Conductive Hearing Loss; Single-Sided Deafness; Mixed Hearing Loss
• Intervention / Treatment: Device: Osia 2 System

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 Published and unpublished data suggest significant pre to postoperative benefit and minimal risk in both children and adults who have received the Osia system.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 Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85013
      • Barrow Neurological Institute
  • California
    • Palo Alto, California, United States, 94304
      • Stanford University
    • San Diego, California, United States, 92123
      • Rady Children's Hospital
  • Minnesota
    • Minneapolis, Minnesota, United States, 55404
      • Children's Minnesota
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • University Hospitals Cleveland Medical Center
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Children's Hospital of Philadelphia
  • Texas
    • Houston, Texas, United States, 77030
      • Texas Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 11 years (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. 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).
2. 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.
3. 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)

Exclusion Criteria:

1. Insufficient bone quality or quantity to support implantation of both the BI300 Implant and the OSI200 Implant.
2. Chronic or non-revisable vestibular or balance disorders that could prevent benefit from the device, as determined by the investigator.
3. Abnormally progressive hearing loss.
4. Evidence that hearing loss is bilateral retro cochlear or bilateral central origin.
5. Evidence of conditions that would prevent speech recognition improvement as determined by the investigator.
6. Skin or scalp conditions that may preclude attachment of the Sound Processor or that may interfere with the use of the Sound Processor.
7. Unable or unwilling to comply with the requirements of the clinical investigation as determined by the Investigator.
8. Investigator site personnel directly affiliated with this study and/or their immediate families; immediate family is defined as a spouse, parent, child, or sibling.
9. Cochlear employees or employees of Contract Research Organizations or contractors engaged by Cochlear for the purposes of this investigation.
10. 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.
11. Individuals undergoing simultaneous single-stage aural atresia or microtia repair due to the increased risk of skin complications associated with ear reconstruction.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: To demonstrate the safety of the Osia 2 System in a pediatric population aged 5 - 11 years.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	Baseline before surgery, 6 months post-surgery

Collaborators and Investigators

• Sponsor: Cochlear
• Collaborators: Analytical Solutions Group, Inc.; R. P. Chiacchierini Consulting, LLC
• Investigators: Study Director: Lori O'Neill, Cochlear

Study record dates

Study Major Dates

• Study Start (Actual): January 26, 2022
• Primary Completion (Actual): September 22, 2023
• Study Completion (Actual): March 14, 2024

Study Registration Dates

• First Submitted: July 23, 2021
• First Submitted That Met QC Criteria: August 4, 2021
• First Posted (Actual): August 11, 2021

Study Record Updates

• Last Update Posted (Estimated): December 11, 2024
• Last Update Submitted That Met QC Criteria: November 22, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Ear Diseases; Hearing Disorders; Hearing Loss; Deafness; Hearing Loss, Conductive; Hearing Loss, Mixed Conductive-Sensorineural
• Other Study ID Numbers: CAM 5766

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes