Back to resultsEvaluation of the Benefits of Bilateral Fitting in BAHS Users
Primary Purpose
Bilateral Hearing Loss
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Fitting of Ponto 3 SuperPower
Sponsored by
About this trial
This is an interventional basic science trial for Bilateral Hearing Loss focused on measuring Bone anchored hearing systems, BAHS, Bilateral benefit, Ponto 3 SuperPower, Minimum Audible Angle, Auditory working memory
Eligibility Criteria
Inclusion Criteria:
- Adult BAHS users, minimum 18 years and maximum 75 years.
- Native English speakers.
- Patients that are already bilaterally implanted.
- Patients with a bilateral conductive or mixed conductive-sensorineural hearing loss.
- Experience with bilateral Ponto of at least 6 months.
- Patients that are using both their sound processors daily.
- PTA BC (at 0.5, 1, 2, 3 kHz) on both sides lower or equal to 65 dB HL.
- If the masked BC is available on the patient's journal, the average difference in masked BC (at 0.5, 1, 2, 4 kHz) between L and R ear should be lower than 15 dB.
- If the masked BC is not available on the patient's journal, the average difference in unmasked BC (at 0.5, 1, 2, 4 kHz) between L and R ear should be lower than 15 dB.
Exclusion Criteria:
- Not deemed suited by the principal investigator.
- If the physician assesses that the patient is not fit for trial participation at any stage.
- Audiogram at 1st visit shows too large masked BC thresholds (PTA BC - at 0.5, 1, 2, 3 kHz - on either side larger than 65 dB HL).
- Audiogram at 1st visit shows asymmetric masked BC thresholds (average difference in masked BC - at 0.5, 1, 2, 4 kHz - between L and R ear larger or equal to 15 dB).
Sites / Locations
- Audiology Department, Nuffield House, University Hospitals Birmingham
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Ponto 3 SuperPower sound processor
Arm Description
All patients will be fitted with two bone-anchored sound processors (Ponto 3 SuperPower), unilaterally and bilaterally.
Outcomes
Primary Outcome Measures
Minimum Audible Angle test
Minimum angle at which noise bursts are accurately localized (Right/Left) in the unilateral and bilateral conditions
Secondary Outcome Measures
SWIR test
Percentage of recalled words in the unilateral and bilateral conditions
SSQ12
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"
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04006132
Brief Title
Evaluation of the Benefits of Bilateral Fitting in BAHS Users
Official Title
Evaluation of the Benefits of Bilateral Fitting in Bone-anchored Hearing System Users
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
July 4, 2019 (Actual)
Primary Completion Date
January 7, 2020 (Actual)
Study Completion Date
January 10, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Oticon Medical
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate the benefit of bilateral implantation with bone-anchored hearing systems (BAHS), in terms of sound localization abilities, as well as auditory working memory. The hypothesis is that the use of two BAHS (bilateral condition) will not only improve localization abilities, but it will also increase the ability to retain words in working memory, compared to performance with only one BAHS (unilateral condition).
Detailed Description
The patients included in this study are adult patients with a bilateral conductive or mixed hearing loss, that are already bilaterally implanted with two percutaneous bone-anchored devices (BAHS). The study consists of two visits. At visit 1, the patients are fitted unilaterally and bilaterally with the investigational device (Ponto 3 SuperPower). After fitting, the patients perform a test of spatial resolution (minimum audible angle, visit 1) and an auditory working memory test (visit 2). These two outcome measures are conducted in the laboratory using the Ponto 3 SuperPower unilaterally and bilaterally. Additionally, the patients fill in a questionnaire (SSQ12) to report perceived performance in their everyday life with their own devices. This is a post market study and all products used are CE marked and used in clinical practice worldwide.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bilateral Hearing Loss
Keywords
Bone anchored hearing systems, BAHS, Bilateral benefit, Ponto 3 SuperPower, Minimum Audible Angle, Auditory working memory
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Masking Description
The participants are blinded to the tested condition (unilateral vs bilateral)
Allocation
N/A
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ponto 3 SuperPower sound processor
Arm Type
Experimental
Arm Description
All patients will be fitted with two bone-anchored sound processors (Ponto 3 SuperPower), unilaterally and bilaterally.
Intervention Type
Device
Intervention Name(s)
Fitting of Ponto 3 SuperPower
Intervention Description
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.
Primary Outcome Measure Information:
Title
Minimum Audible Angle test
Description
Minimum angle at which noise bursts are accurately localized (Right/Left) in the unilateral and bilateral conditions
Time Frame
4 months
Secondary Outcome Measure Information:
Title
SWIR test
Description
Percentage of recalled words in the unilateral and bilateral conditions
Time Frame
4 months
Title
SSQ12
Description
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"
Time Frame
4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Adult BAHS users, minimum 18 years and maximum 75 years.
Native English speakers.
Patients that are already bilaterally implanted.
Patients with a bilateral conductive or mixed conductive-sensorineural hearing loss.
Experience with bilateral Ponto of at least 6 months.
Patients that are using both their sound processors daily.
PTA BC (at 0.5, 1, 2, 3 kHz) on both sides lower or equal to 65 dB HL.
If the masked BC is available on the patient's journal, the average difference in masked BC (at 0.5, 1, 2, 4 kHz) between L and R ear should be lower than 15 dB.
If the masked BC is not available on the patient's journal, the average difference in unmasked BC (at 0.5, 1, 2, 4 kHz) between L and R ear should be lower than 15 dB.
Exclusion Criteria:
Not deemed suited by the principal investigator.
If the physician assesses that the patient is not fit for trial participation at any stage.
Audiogram at 1st visit shows too large masked BC thresholds (PTA BC - at 0.5, 1, 2, 3 kHz - on either side larger than 65 dB HL).
Audiogram at 1st visit shows asymmetric masked BC thresholds (average difference in masked BC - at 0.5, 1, 2, 4 kHz - between L and R ear larger or equal to 15 dB).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William Brassington
Organizational Affiliation
University Hospitals Birmingham, United Kingdom
Official's Role
Principal Investigator
Facility Information:
Facility Name
Audiology Department, Nuffield House, University Hospitals Birmingham
City
Birmingham
State/Province
West Midlands
ZIP/Postal Code
B15 2TH
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Evaluation of the Benefits of Bilateral Fitting in BAHS Users
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