Osia 2 System for Mixed Hearing Loss

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Stanford University, Palo Alto, CA
Mixed Hearing Loss+5 More
Osia 2 System - Device
Eligibility
< 18
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether the Cochlear Osia 2 system is safe and effective for children.

See full description

Eligible Conditions

  • Mixed Hearing Loss
  • Hearing Loss, Conductive
  • Single-Sided Deafness

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Mixed Hearing Loss

Study Objectives

This trial is evaluating whether Osia 2 System will improve 2 primary outcomes and 4 secondary outcomes in patients with Mixed Hearing Loss. Measurement will happen over the course of Baseline before surgery, 4 weeks post-surgery.

12 months
Number of adverse events quantified by type, frequency, and severity between surgery and 12-months post-surgery.
6 months post-surgery
Number of adverse events quantified by type, frequency, and severity between surgery and 6-months post-surgery.
Week 4
Change from baseline to 4-weeks post-surgery in unaided bone conduction thresholds.
Month 6
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.
Change in word recognition using CNC words presented in quiet from baseline to 6-months post-surgery.

Trial Safety

Safety Progress

1 of 3

Other trials for Mixed Hearing Loss

Trial Design

1 Treatment Group

To demonstrate the safety of the Osia 2 System in a pediatric population aged 5 ...
1 of 1
Experimental Treatment

This trial requires 50 total participants across 1 different treatment group

This trial involves a single treatment. Osia 2 System is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

To demonstrate the safety of the Osia 2 System in a pediatric population aged 5 - 11 years.
Device
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Osia 2 System
2020
N/A
~20

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 12 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 12 months for reporting.

Closest Location

Stanford University - Palo Alto, CA

Eligibility Criteria

This trial is for patients born any sex aged 18 and younger. There are 4 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Some people who already have a bone-anchored hearing device, or are seeking a new implantation unilaterally, may want to get a second-side implant in the future. show original
Having experience with amplified sound through a properly fitted amplification device such as a hearing aid, CROS device, or bone conduction device on a softband or sound arc. show original
If someone has a conductive or mixed hearing loss and still can benefit from sound amplification, their pure tone average bone conduction threshold should be better than or equal to 55 dB HL show original
Someone who is willing and able to provide written informed consent for a study participant. show original

Patient Q&A Section

How many people get hearing loss, conductive a year in the United States?

"Approximately 1.8 million people a year who have conductive hearing loss in the United States. There are about 2.1 million people with hearing loss due to occupational noise." - Anonymous Online Contributor

Unverified Answer

What causes hearing loss, conductive?

"Conductive hearing loss in children is usually related to certain infectious, genetic and obstetric conditions. The most common cause of congenital hearing loss is fetal infection of ear canal. It is the most common cause of otitis media in child and is therefore an important clinical problem. Otitis media is also the most common cause of hearing loss in adults." - Anonymous Online Contributor

Unverified Answer

What are the signs of hearing loss, conductive?

"The use of a hearing aid may increase the difficulty of hearing in noise conditions, especially in environments with excessive background noise. The use of a hearing aid may increase the difficulty in understanding spoken words or music, especially in noise (but may decrease the perceived severity of noise-induced hearing loss)." - Anonymous Online Contributor

Unverified Answer

What is hearing loss, conductive?

"For many patients, hearing loss, conductive, and normal hearing are equally important factors at the clinic regarding the subjective assessment of the patient's hearing. Hearing aid amplification should be based on the need rather than the patient's age." - Anonymous Online Contributor

Unverified Answer

Can hearing loss, conductive be cured?

"The hearing loss and conductive hearing loss are associated, but hearing loss, conductive can be cured in some cases. In some cases there are associated hearing disturbances. However, when combined, they are less common." - Anonymous Online Contributor

Unverified Answer

What are common treatments for hearing loss, conductive?

"Treatment for unilateral conductive losses generally includes a combination of hearing aids and medication. Hearing aids can help improve speech in noise, and medication, whether antibiotics, anticoagulants and/or antiepileptics may be prescribed depending on the cause and severity of conductive hearing loss. Otolaryngologists should be consulted for diagnosis or treatment of hearing loss in children and adolescents." - Anonymous Online Contributor

Unverified Answer

Does hearing loss, conductive run in families?

"There is evidence of an increased risk of hearing loss and conductive hearing loss in individuals with conductive hearing loss, family history of diabetes mellitus and in individuals with parental diabetes mellitus." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of hearing loss, conductive?

"Hearing loss, conductive, is the most common presentation of hearing loss. If conductive hearing loss is suspected, a brief hearing history is the appropriate way to screen in the primary care setting. The main cause of conductive hearing loss is acoustic trauma, especially from industrial noise exposures." - Anonymous Online Contributor

Unverified Answer

How does osia 2 system work?

"Osia 2 systems help patients with hearing loss maintain the ability to understand speech and communicate with others despite their hearing loss. However, in some situations they are less effective at achieving these communications goals than patients with normal hearing. Further research on the speech processor and speech communication mode is needed to understand the factors that decrease the effectiveness for certain hearing profiles or acoustic environments." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for hearing loss, conductive?

"Patients with cochlear implants and those eligible for clinical trials have varying levels of knowledge about clinical trials and are less likely to participate in such trials compared with those who have normal hearing levels." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving osia 2 system?

"There have been several other clinical trials involving osia 2 system; however, there is no existing evidence that this treatment has been effective in this type of hearing loss. There have been no studies to support any conclusions about this system using a large sample of subjects. In fact, there has never been any meta-analysis of the effectiveness of osia 2 system. There is also not, there is a lack of any evidence to support this system to patients, physicians, and policymakers. A lack of evidence isn't necessarily a lack of evidence; it a lack of knowledge." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets hearing loss, conductive?

"The average age people get hearing loss, conductive, is 57 years old. Hearing loss, conductive, is mostly [related to] lifestyle choices, age-related diseases, occupational factors, and [or is] noise exposure. However, hearing loss, conductive, is more common in men than in women. There is a link between age-related diseases and hearing loss, conductive. There is a higher prevalence of hearing loss, conductive, in African American children [compared to Caucasian children] and American Indian children." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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