Back to resultsAssessment of Novel Sound Changing Principles in Hearing Instruments to Determine Their Application - Sonova2018_31
Primary Purpose
Hearing Loss
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Bolero B90-SP
Sponsored by
About this trial
This is an interventional treatment trial for Hearing Loss
Eligibility Criteria
Inclusion Criteria:
- Adult hearing impaired persons (minimum age: 18 years) with or without experience with hearing aids
- Sensorineural hearing loss (N4-N6 according to ISO 60118-15)
- Good written and spoken (Swiss) German language skills
- Healthy outer ear
- Informed Consent as documented by signature
- Symmetric hearing loss below 1000 Hz
Exclusion Criteria:
- Contraindications to the MD in this study, e.g. known hypersensitivity or allergy to the investigational product
- Limited mobility and not in the position to attend weekly appointments on study site
- Inability to produce a reliable hearing test result
- Known psychological problems
- Central hearing disorders
Sites / Locations
- Sonova AG
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
Hearing Aid with beam form principle_A
Hearing Aid with beam form principle_B
Hearing Aid with beam form principle_C
Arm Description
Device: Hearing Aid beam former principle_A (simulation of real ear condition). Each participant will be fitted with the 3 different beam former (directionality change) principles on the same hearing aid, saved to 3 manual programs. Beam former principle is a sound processing algorithm to focus to a target source in a noisy situation to improve the speech intelligibility and comfort. The experimental conditions vary in their parametrization to result in different degrees of beam forming and good speech quality.
Device: Hearing Aid beam former principle_B. Each participant will be fitted with the 3 different beam former (directionality change) principles on the same hearing aid, saved to 3 manual programs. Beam former principle is a sound processing algorithm to focus to a target source in a noisy situation to improve the speech intelligibility and comfort. The experimental conditions vary in their parametrization to result in different degrees of beam forming and good speech quality.
Device: Hearing Aid beam former principle_C. Each participant will be fitted with the 3 different beam former (directionality change) principles on the same hearing aid, saved to 3 manual programs. Beam former principle is a sound processing algorithm to focus to a target source in a noisy situation to improve the speech intelligibility and comfort. The experimental conditions vary in their parametrization to result in different degrees of beam forming and good speech quality.
Outcomes
Primary Outcome Measures
Individual binaural Hearing abilities
Primary Outcome measurement is to measure the speech understanding in noise [SNR in dB] for the beam former principles A, B and C
Secondary Outcome Measures
Speechunderstanding for different beam form principles
Secondary Outcome measurement is to measure individual binaural Hearing abilities with psycho acoustical test principles (Binaural inter aural Level difference [SNR in dB] and Binaural Masking Level Difference [SNR in dB] and speech test [Oldenburger Satztest in noise [SNR in dB]. Thereby, the correlation between psycho acoustical test results and speech test results will be analyzed.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03699735
Brief Title
Assessment of Novel Sound Changing Principles in Hearing Instruments to Determine Their Application - Sonova2018_31
Official Title
Assessment of Novel Sound Changing Principles in Hearing Instruments to Determine Their Application
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
August 6, 2018 (Actual)
Primary Completion Date
December 20, 2018 (Actual)
Study Completion Date
March 29, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sonova AG
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
A methodical evaluation of sound changing principles in CE-labelled Sonova brand hearing instruments (e.g. Phonak hearing instruments) is intended to be conducted on hearing impaired participants. These sound changing principles are enabled by respective hearing instrument technologies and hearing instrument algorithms. The aim of the study is to investigate and asses strength and weaknesses of these sound changing principles in terms of hearing performance to determine their application in hearing instruments (Phase of development). Objective laboratory measurements will be carried out. This will be a controlled, single blinded and randomised active comparator clinical evaluation which will be conducted mono centric at Sonova AG Headquarter based in Stäfa
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Crossover Assignment Each participant will be treated with each test condition in a randomized order.
Masking
Participant
Masking Description
Single (Participant)
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Hearing Aid with beam form principle_A
Arm Type
Active Comparator
Arm Description
Device: Hearing Aid beam former principle_A (simulation of real ear condition). Each participant will be fitted with the 3 different beam former (directionality change) principles on the same hearing aid, saved to 3 manual programs. Beam former principle is a sound processing algorithm to focus to a target source in a noisy situation to improve the speech intelligibility and comfort. The experimental conditions vary in their parametrization to result in different degrees of beam forming and good speech quality.
Arm Title
Hearing Aid with beam form principle_B
Arm Type
Experimental
Arm Description
Device: Hearing Aid beam former principle_B. Each participant will be fitted with the 3 different beam former (directionality change) principles on the same hearing aid, saved to 3 manual programs. Beam former principle is a sound processing algorithm to focus to a target source in a noisy situation to improve the speech intelligibility and comfort. The experimental conditions vary in their parametrization to result in different degrees of beam forming and good speech quality.
Arm Title
Hearing Aid with beam form principle_C
Arm Type
Experimental
Arm Description
Device: Hearing Aid beam former principle_C. Each participant will be fitted with the 3 different beam former (directionality change) principles on the same hearing aid, saved to 3 manual programs. Beam former principle is a sound processing algorithm to focus to a target source in a noisy situation to improve the speech intelligibility and comfort. The experimental conditions vary in their parametrization to result in different degrees of beam forming and good speech quality.
Intervention Type
Device
Intervention Name(s)
Bolero B90-SP
Intervention Description
Behind the ear Hearing device fitted with an individual ear mold to compensate a Hearing loss
Primary Outcome Measure Information:
Title
Individual binaural Hearing abilities
Description
Primary Outcome measurement is to measure the speech understanding in noise [SNR in dB] for the beam former principles A, B and C
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Speechunderstanding for different beam form principles
Description
Secondary Outcome measurement is to measure individual binaural Hearing abilities with psycho acoustical test principles (Binaural inter aural Level difference [SNR in dB] and Binaural Masking Level Difference [SNR in dB] and speech test [Oldenburger Satztest in noise [SNR in dB]. Thereby, the correlation between psycho acoustical test results and speech test results will be analyzed.
Time Frame
2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult hearing impaired persons (minimum age: 18 years) with or without experience with hearing aids
Sensorineural hearing loss (N4-N6 according to ISO 60118-15)
Good written and spoken (Swiss) German language skills
Healthy outer ear
Informed Consent as documented by signature
Symmetric hearing loss below 1000 Hz
Exclusion Criteria:
Contraindications to the MD in this study, e.g. known hypersensitivity or allergy to the investigational product
Limited mobility and not in the position to attend weekly appointments on study site
Inability to produce a reliable hearing test result
Known psychological problems
Central hearing disorders
Facility Information:
Facility Name
Sonova AG
City
Stäfa
State/Province
Zürich
ZIP/Postal Code
8712
Country
Switzerland
12. IPD Sharing Statement
Learn more about this trial
Assessment of Novel Sound Changing Principles in Hearing Instruments to Determine Their Application - Sonova2018_31
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