What is the mechanism of action of this treatment?

Conductive hearing loss occurs when sound waves are not efficiently conducted through the outer ear, tympanic membrane, or middle ear. Bone conduction hearing technology, such as the Cochlear Osia 2 System, bypasses these structures by transmitting sound vibrations directly to the inner ear via the skull bone. This mechanism is crucial for patients with conductive hearing loss because it allows them to perceive sound without relying on the impaired conductive pathway. By directly stimulating the cochlea, bone conduction devices can significantly improve hearing outcomes and quality of life for these patients.

What side effects are associated with this type of intervention?

Common treatments for conductive hearing loss, such as bone conduction hearing technologies like the Cochlear Osia 2 System, generally have minimal risks. However, potential side effects can include skin irritation or infection at the implant site, device failure, and the need for surgical revision. Additionally, there may be a risk of pain or discomfort around the implant area, and in rare cases, complications such as implant extrusion or adverse reactions to anesthesia during the surgical procedure.

What prior FDA approvals exist?

The Cochlear Osia 2 System, a bone conduction hearing technology, was cleared by the FDA on November 15, 2019, for individuals aged 12 years and older with conductive or mixed hearing loss (up to 55 dB HL) or single-sided deafness (SSD). This system represents a significant advancement in the treatment of conductive hearing loss, offering a minimally invasive option that bypasses the damaged outer or middle ear to directly stimulate the cochlea. Other similar FDA-approved treatments include various bone-anchored hearing aids (BAHAs) that also utilize bone conduction to improve hearing in patients with conductive hearing loss.

What other types of research exist?

Promising alternatives to the Cochlear Osia 2 System for conductive hearing loss patients include the following: 1) Bonebridge by MED-EL, which is an active bone conduction implant that has shown positive outcomes in clinical studies. 2) Baha 6 Max by Cochlear, which offers improved sound quality and connectivity features. 3) ADHEAR by MED-EL, a non-surgical bone conduction system that has been well-received for its ease of use and effectiveness. These devices represent significant advancements in bone conduction hearing technology and are worth considering for treatment in 2024.

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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

Must not have

Abnormally progressive hearing loss

Skin or scalp conditions that may preclude attachment of the Sound Processor or interfere with its use

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from implantation to 6 months post-surgery

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to test the safety and effectiveness of the Cochlear Osia 2 System in children with specific types of hearing loss. The device helps them hear better by sending sound through the bones in their skull. The Cochlear Osia System is a new device for certain types of hearing loss and has shown significant improvements in hearing and quality of life in previous studies.

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.

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.

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

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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.

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I am aged 5-11 with severe hearing loss in one ear and normal hearing in the other.

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I am aged 5-11 with hearing loss that improves with sound amplification.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My hearing is getting worse quickly.

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I don't have skin or scalp issues that would affect using a Sound Processor.

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My bones are not strong or large enough for two specific implants.

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I have long-term balance issues that can't be fixed with surgery.

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My hearing loss is due to issues beyond the ear in both ears.

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I am having surgery for both ear canal and outer ear issues at the same time.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from implantation to 6 months post-surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from implantation to 6 months post-surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and from implantation to 6 months post-surgery for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of Adverse Events Quantified by Type and Severity Between Implantation and 6-months Post-surgery.

Secondary study objectives

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

Change From Baseline to 6-months Post-surgery in SSQ (Speech, Spatial and Qualities of Hearing Scale) Parent Questionnaire

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.

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 9Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Conductive hearing loss occurs when sound waves are not efficiently conducted through the outer ear, tympanic membrane, or middle ear. Bone conduction hearing technology, such as the Cochlear Osia 2 System, bypasses these structures by transmitting sound vibrations directly to the inner ear via the skull bone. This mechanism is crucial for patients with conductive hearing loss because it allows them to perceive sound without relying on the impaired conductive pathway. By directly stimulating the cochlea, bone conduction devices can significantly improve hearing outcomes and quality of life for these patients.