Back to resultsInvestigation of an Updated Bone-anchored Sound Processor
Primary Purpose
Hearing Loss, Hearing Loss, Conductive, Hearing Loss, Mixed
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Device A
Device B
Sponsored by
About this trial
This is an interventional prevention trial for Hearing Loss focused on measuring BAHS, Ponto
Eligibility Criteria
Inclusion Criteria:
- Signed Informed Consent Form
- Adult subjects (18 years or older)
- Subjects using a Ponto 3 SuperPower on Oticon Medical compatible abutment
- Experienced BAHS users with a minimum experience of 3 months.
Subjects with:
- conductive or mixed hearing loss with pure tone average (PTA) bone conduction (BC) threshold (measured at 0.5, 1, 2 and 3 kHz) of the indicated ear better than or equal to 65 dB HL as measured in situ with Ponto 3 SuperPower at Visit 1.
- OR subjects who have a profound sensorineural hearing loss in one ear and normal hearing in the opposite ear (i.e., SSD). The pure tone average (PTA) air conduction (AC) threshold of the hearing ear should then be better than or equal to 20 dB HL (measured at 0.5, 1, 2 and 3 kHz) as reported in the patient's Noah file.
- OR subjects who are indicated for an air-conduction contralateral routing of signals (AC CROS) hearing aid, but who for some reason cannot or will not use an AC CROS (as per investigator discretion).
- Fluent in Danish
Exclusion Criteria:
Subjects meeting any of the following criteria will not be permitted to participate in the investigation:
- Known abnormally progressive BC hearing loss as judged by the investigator
- Subjects with known mixed losses where the sensorineural part of the hearing loss is of retro-cochlear or central origin
- Participation in another clinical investigation which might cause interference with study participation.
- Subjects who do not have the ability or are un-willing to follow investigational procedures/requirements, e.g. to complete questionnaires, according to investigator's discretion.
Sites / Locations
- Oticon Medical c/o Oticon A/S
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
AAB
ABA
Arm Description
Starts with Device A in first and second trial period and change to Device B in third trial period.
Starts with Device A in first trial period, wears Device B in second trial period and change to Device A in third trial period.
Outcomes
Primary Outcome Measures
To demonstrate that OSN in Device A provides subjects with improved speech recognition in noise.
Difference in signal-to-noise ratio at 70% correct (referred to as SRT70) between OSN OFF and OSN ON after field trial with Device A (incl. automatics).
Secondary Outcome Measures
To assess the preference of BAHS sound processor.
Percentage (%) of subjects who prefer Device A over Device B in noisy sound environments.
To assess the improvement of hearing with Device A.
Functional gain with Device A, i.e. the difference in dB between unaided and aided sound field thresholds, for frequencies 250, 500, 1000, 2000, 3000, 4000, 6000 and 8000 Hz.
Functional gain with Device A, see definition above, calculated on average for frequencies 500, 1000, 2000 and 4000 Hz (PTA4).
To assess the degree to which Device A compensates for the BC hearing loss for the group CHL/MHL
Effective gain defined as the difference in dB between aided sound field thresholds with Device A, and BC in-situ thresholds on the aided ear(s). The effective gain is calculated for frequencies 250, 500, 1000, 2000, 3000, 4000, 6000 and 8000 Hz.
Effective gain with Device A, see definition above, calculated in average for frequencies 500, 1000, 2000 and 4000 Hz (PTA4).
To assess the improvement in speech recognition with Device A in quiet.
Difference in speech recognition score in percent between unaided and aided, assessed in quiet on the aided ear(s).
To assess performance in speech recognition in noise with Device A and Device B in Omni settings.
Difference in SRT70 between Device A and Device B in Omni settings as measured at Visit 1.
To assess the improvement in speech recognition in noise with Device B in full directional settings as compared to omnidirectional.
Difference in signal-to-noise ratio at 70% correct (referred to as SRT70) between Omni and Full Dir after field trial with Device B.
To compare the improvement in speech recognition in noise with OSN ON in Device A (re Omni) with the improvement of full directionality in Device B (re Omni).
Comparison of the difference in SRT70 between OSN OFF vs. OSN ON in Device A and Omni vs. Full Dir in Device B.
To assess self-reported performance with Device A and Device B.
Average SSQ12 scores with Device A for each question, sub-scales and in total.
Average SSQ12 scores with Device B for each question, sub-scales and in total.
Difference in SSQ12 scores between Device A and Device B for each question, sub-scales and in total.
To assess self-reported ratings of sound quality, speech intelligibility, and overall performance with Device A and Device B.
Average ratings with Device A for each question of the "SPSK sound quality" questionnaire completed during the 1. field trial with Device A as obtained via phone interview
Average ratings with Device A for each question of the "SPSK sound quality" questionnaire completed during the 2. or 3. field trial with Device A
Average ratings with Device B for each question of the "SPSK sound quality" questionnaire completed during the 2. or 3. field trial with Device B
Difference in ratings between Device A and Device B for each question of the "SPSK sound quality" questionnaire
Average ratings with Device A for each question of the "SPSK situations" questionnaire completed during the 2. or 3. field trial with Device A
Average ratings with Device B for each question of the "SPSK situations" questionnaire completed during the 2. or 3. field trial with Device B
Difference in ratings between Device A and Device B for each question of the "SPSK situations" questionnaire
To assess the difference in BC thresholds as measured in-situ with Device A and via conventional BC audiometry.
Difference in dB between BC in situ thresholds and BC thresholds measured with conventional BC audiometry.
To assess the difference in BC thresholds as measured in-situ with Device A and Device B.
Difference in dB between BC in situ thresholds measured with Device A and Device B.
To confirm the safety profile of the Device A in terms of the occurrence of adverse events and serious adverse events.
Tabulated adverse events and serious adverse event related to the Device A reported throughout the study.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05086809
Brief Title
Investigation of an Updated Bone-anchored Sound Processor
Official Title
BC109 - Investigation of an Updated Bone-anchored Sound Processor
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
September 30, 2021 (Actual)
Primary Completion Date
December 13, 2021 (Actual)
Study Completion Date
December 13, 2021 (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
Data Monitoring Committee
No
5. Study Description
Brief Summary
The study is a prospective, single-center, comparative, cross-over study with within-subject control design. In the investigation an updated sound processor will be tested at compared to the CE marked Ponto 3 SuperPower sound processor (available on the market since December 2016) in order to establish marketing claim(s) on the updated sound processor.
The performance of the two sound processors will be evaluated via speech and hearing tests, and patient reported outcomes.
Detailed Description
The investigation is a premarket investigation with the purpose of gathering knowledge on the performance of an updated sound processor compared to the CE marked Ponto 3 SuperPower sound processor to establish marketing claim(s) on the updated sound processor.
The recruitment for this clinical investigation will be performed among subjects who have already received a Ponto 3 SuperPower sound processor as a minimum three month prior to the study. 12-15 adult Ponto 3 SuperPower users with a conductive, mixed hearing loss or single-sided deafness will be included.
The study is a prospective, single-center, comparative, cross-over study with within-subject control design. The study includes four laboratory visits and three field trial periods. After the first trial period, which is included to ensure a homogenous baseline, the study is designed as a two-period, two-sequence crossover trial to compare the two sound processors (Device A & Device B). Each participant is randomized into one of two sequences: (1) Device A then B, or (2) Device B then A, such that (about) half of the participants are assigned to one sequence and the other half to the second sequence.
This study is designed to combine audiological assessments (hearing and speech tests) in the laboratory and subjective self-reported outcomes collected during and after field trial periods with the investigational device and the comparator device (Ponto 3 SuperPower). The primary outcome of this study is to demonstrate that Open Sound Navigator in the updated sound processor provides subjects with improved speech recognition in noise.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss, Hearing Loss, Conductive, Hearing Loss, Mixed, Hearing Disorders, Deafness, Ear Diseases, Otorhinolaryngologic Diseases, Sensation Disorders, Neurologic Manifestations, Nervous System Diseases
Keywords
BAHS, Ponto
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
The study includes four laboratory visits and three field trial periods. The first trial period is included to ensure a homogenous baseline. After the first trial period, the study is designed as a two-period, two-sequence crossover trial to compare two sound processors (Device A & Device B). Each participant is randomized into one of two sequences: (1) Device A then B, or (2) Device B then A, such that (about) half of the participants are assigned to one sequence and the other half to the second sequence.
Masking
Participant
Masking Description
The participants are blinded to the tested conditions in the lab, used for assessment of the primary objective, but the participants are not blinded to the sound processors used during the three trial periods, due to different appearance of the sound processors, making it possible to distinguish between the sound processors.
Allocation
Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AAB
Arm Type
Active Comparator
Arm Description
Starts with Device A in first and second trial period and change to Device B in third trial period.
Arm Title
ABA
Arm Type
Active Comparator
Arm Description
Starts with Device A in first trial period, wears Device B in second trial period and change to Device A in third trial period.
Intervention Type
Device
Intervention Name(s)
Device A
Intervention Description
Participant wear Device A and evaluate the performance of the device.
Intervention Type
Device
Intervention Name(s)
Device B
Intervention Description
Participant wear Device B and evaluate the performance of the device.
Primary Outcome Measure Information:
Title
To demonstrate that OSN in Device A provides subjects with improved speech recognition in noise.
Description
Difference in signal-to-noise ratio at 70% correct (referred to as SRT70) between OSN OFF and OSN ON after field trial with Device A (incl. automatics).
Time Frame
4 weeks or 6 weeks
Secondary Outcome Measure Information:
Title
To assess the preference of BAHS sound processor.
Description
Percentage (%) of subjects who prefer Device A over Device B in noisy sound environments.
Time Frame
6 weeks
Title
To assess the improvement of hearing with Device A.
Description
Functional gain with Device A, i.e. the difference in dB between unaided and aided sound field thresholds, for frequencies 250, 500, 1000, 2000, 3000, 4000, 6000 and 8000 Hz.
Functional gain with Device A, see definition above, calculated on average for frequencies 500, 1000, 2000 and 4000 Hz (PTA4).
Time Frame
Baseline
Title
To assess the degree to which Device A compensates for the BC hearing loss for the group CHL/MHL
Description
Effective gain defined as the difference in dB between aided sound field thresholds with Device A, and BC in-situ thresholds on the aided ear(s). The effective gain is calculated for frequencies 250, 500, 1000, 2000, 3000, 4000, 6000 and 8000 Hz.
Effective gain with Device A, see definition above, calculated in average for frequencies 500, 1000, 2000 and 4000 Hz (PTA4).
Time Frame
Baseline
Title
To assess the improvement in speech recognition with Device A in quiet.
Description
Difference in speech recognition score in percent between unaided and aided, assessed in quiet on the aided ear(s).
Time Frame
2 weeks
Title
To assess performance in speech recognition in noise with Device A and Device B in Omni settings.
Description
Difference in SRT70 between Device A and Device B in Omni settings as measured at Visit 1.
Time Frame
Baseline
Title
To assess the improvement in speech recognition in noise with Device B in full directional settings as compared to omnidirectional.
Description
Difference in signal-to-noise ratio at 70% correct (referred to as SRT70) between Omni and Full Dir after field trial with Device B.
Time Frame
4 weeks or 6 weeks
Title
To compare the improvement in speech recognition in noise with OSN ON in Device A (re Omni) with the improvement of full directionality in Device B (re Omni).
Description
Comparison of the difference in SRT70 between OSN OFF vs. OSN ON in Device A and Omni vs. Full Dir in Device B.
Time Frame
4 weeks or 6 weeks
Title
To assess self-reported performance with Device A and Device B.
Description
Average SSQ12 scores with Device A for each question, sub-scales and in total.
Average SSQ12 scores with Device B for each question, sub-scales and in total.
Difference in SSQ12 scores between Device A and Device B for each question, sub-scales and in total.
Time Frame
4 weeks or 6 weeks
Title
To assess self-reported ratings of sound quality, speech intelligibility, and overall performance with Device A and Device B.
Description
Average ratings with Device A for each question of the "SPSK sound quality" questionnaire completed during the 1. field trial with Device A as obtained via phone interview
Average ratings with Device A for each question of the "SPSK sound quality" questionnaire completed during the 2. or 3. field trial with Device A
Average ratings with Device B for each question of the "SPSK sound quality" questionnaire completed during the 2. or 3. field trial with Device B
Difference in ratings between Device A and Device B for each question of the "SPSK sound quality" questionnaire
Average ratings with Device A for each question of the "SPSK situations" questionnaire completed during the 2. or 3. field trial with Device A
Average ratings with Device B for each question of the "SPSK situations" questionnaire completed during the 2. or 3. field trial with Device B
Difference in ratings between Device A and Device B for each question of the "SPSK situations" questionnaire
Time Frame
1 week, 4 weeks and 6 weeks
Title
To assess the difference in BC thresholds as measured in-situ with Device A and via conventional BC audiometry.
Description
Difference in dB between BC in situ thresholds and BC thresholds measured with conventional BC audiometry.
Time Frame
Baseline and 2 weeks
Title
To assess the difference in BC thresholds as measured in-situ with Device A and Device B.
Description
Difference in dB between BC in situ thresholds measured with Device A and Device B.
Time Frame
Baseline
Title
To confirm the safety profile of the Device A in terms of the occurrence of adverse events and serious adverse events.
Description
Tabulated adverse events and serious adverse event related to the Device A reported throughout the study.
Time Frame
1 week, 2 weeks, 4 weeks and 6 weeks
Other Pre-specified Outcome Measures:
Title
To assess the improvement in speech recognition in noise with Device A with OSN ON vs. OSN OFF as a function of hearing loss.
Description
Correlation of the difference between OSN OFF and OSN ON after field trial with Device A (incl. automatics) and PTA4 BC in situ for subjects with SSD and subjects with conductive/mixed hearing loss.
Time Frame
Baseline and week 4 or week 6
Title
To list comments and reactions from the subjects with Device A and Device B.
Description
Immediate reactions collected with each sound processor before field trial.
Time Frame
Baseline, 2 weeks and 4 weeks
Title
To list comments and reactions from the subjects with Device A and Device B.
Description
Comments on any difference between phone interview and subject's feedback collected at V2 after first field trial with Device A (without automatics).
Time Frame
2 weeks
Title
To assess usage of device for each field trial period.
Description
Average hours of usage of each sound processor for each field trial.
Time Frame
2 weeks, 4 weeks and 6 weeks
Title
To assess usage of device and batteries for each field trial period.
Description
Frequency of battery replacement for each sound processor for each field trial.
Time Frame
2 weeks, 4 weeks and 6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Signed Informed Consent Form
Adult subjects (18 years or older)
Subjects using a Ponto 3 SuperPower on Oticon Medical compatible abutment
Experienced BAHS users with a minimum experience of 3 months.
Subjects with:
conductive or mixed hearing loss with pure tone average (PTA) bone conduction (BC) threshold (measured at 0.5, 1, 2 and 3 kHz) of the indicated ear better than or equal to 65 dB HL as measured in situ with Ponto 3 SuperPower at Visit 1.
OR subjects who have a profound sensorineural hearing loss in one ear and normal hearing in the opposite ear (i.e., SSD). The pure tone average (PTA) air conduction (AC) threshold of the hearing ear should then be better than or equal to 20 dB HL (measured at 0.5, 1, 2 and 3 kHz) as reported in the patient's Noah file.
OR subjects who are indicated for an air-conduction contralateral routing of signals (AC CROS) hearing aid, but who for some reason cannot or will not use an AC CROS (as per investigator discretion).
Fluent in Danish
Exclusion Criteria:
Subjects meeting any of the following criteria will not be permitted to participate in the investigation:
Known abnormally progressive BC hearing loss as judged by the investigator
Subjects with known mixed losses where the sensorineural part of the hearing loss is of retro-cochlear or central origin
Participation in another clinical investigation which might cause interference with study participation.
Subjects who do not have the ability or are un-willing to follow investigational procedures/requirements, e.g. to complete questionnaires, according to investigator's discretion.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mona El Hichou, MSc
Organizational Affiliation
Oticon Medical c/o Oticon A/S
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oticon Medical c/o Oticon A/S
City
Copenhagen
State/Province
Smørum
ZIP/Postal Code
2765
Country
Denmark
12. IPD Sharing Statement
Learn more about this trial
Investigation of an Updated Bone-anchored Sound Processor
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