Evaluation of the Benefits of Bilateral Fitting in BAHS Users
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|ClinicalTrials.gov Identifier: NCT04006132|
Recruitment Status : Completed
First Posted : July 5, 2019
Last Update Posted : January 23, 2020
|Condition or disease||Intervention/treatment||Phase|
|Bilateral Hearing Loss||Device: Fitting of Ponto 3 SuperPower||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||26 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Masking Description:||The participants are blinded to the tested condition (unilateral vs bilateral)|
|Primary Purpose:||Basic Science|
|Official Title:||Evaluation of the Benefits of Bilateral Fitting in Bone-anchored Hearing System Users|
|Actual Study Start Date :||July 4, 2019|
|Actual Primary Completion Date :||January 7, 2020|
|Actual Study Completion Date :||January 10, 2020|
Experimental: Ponto 3 SuperPower sound processor
All patients will be fitted with two bone-anchored sound processors (Ponto 3 SuperPower), unilaterally and bilaterally.
Device: Fitting of Ponto 3 SuperPower
Bone-anchored hearing systems (BAHS) use the body's natural ability to transfer sound through bone conduction. The sound processor picks up sound and converts it into vibrations that are transferred through the skull bone to the inner ear (cochlea). Thus, for patients with conductive or mixed hearing losses, patients with lasting hearing loss following a middle ear disease or malformations (such as microtia), the vibrations are bypassing the conductive problem in the ear canal or middle ear. The intervention in this study is audiologically fitting two bone-anchored sound processors (Ponto 3 SuperPower) to patients that are already bilaterally implanted with abutments.
- Minimum Audible Angle test [ Time Frame: 4 months ]Minimum angle at which noise bursts are accurately localized (Right/Left) in the unilateral and bilateral conditions
- SWIR test [ Time Frame: 4 months ]Percentage of recalled words in the unilateral and bilateral conditions
- SSQ12 [ Time Frame: 4 months ]Subjective performance as measured by Speech, Spatial and Qualities of Hearing questionnaire (SSQ); 12 items with a scale from 0-10 where 0 represents "Not at all" and 10 represents "Perfect"
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04006132
|Audiology Department, Nuffield House, University Hospitals Birmingham|
|Birmingham, West Midlands, United Kingdom, B15 2TH|
|Principal Investigator:||William Brassington||University Hospitals Birmingham, United Kingdom|