Assessment of Novel Sound Changing Principles in Hearing Instruments to Determine Their Application - 2018_16
Primary Purpose
Hearing Loss, Normal Hearing
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Hearing Aid without NR and BF
Hearing Aid with NR
Hearing Aid with BF
Sponsored by
About this trial
This is an interventional treatment trial for Hearing Loss
Eligibility Criteria
Inclusion Criteria:
- Healthy outer ear (without previous surgical procedures)
- Ability to fill in a questionnaire conscientiously
- Informed Consent as documented by signature
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
- Limited ability to describe listening impressions/experiences and the use of the hearing aid
- Inability to produce a reliable hearing test result
- Massively limited dexterity
- Known psychological problems
- Known 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 without NR and BF
Hearing Aid with NR
Hearing Aid with BF
Arm Description
Hearing Aid without Noise Reduction (NR) or beam forming (BF) enabled serves as reference condition.
Hearing Aid with Noise Reduction (NR) enabled.
Hearing Aid with beam forming (BF) enabled.
Outcomes
Primary Outcome Measures
Electroencephalogram (EEG) data
Neural language processing will be assessed through the EEG data collected while the participant is listening to running speech (neurophysiological data). Analysis of the brainstem response, cortical entrainment, N400 and alpha power are planned. EEG data is measured in Volt (mV), and entrainment data is analysed through coherence (frequency-based measure of correlation between the acoustic and the neural signal). N400 and alpha power are measured on the variance of mV over time.
Secondary Outcome Measures
Subjective Listening Effort rating
The subjective Listening Effort rating will be assessed through self-reported individual listening effort on a scale from "extreme effort" to "no effort".
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03578471
Brief Title
Assessment of Novel Sound Changing Principles in Hearing Instruments to Determine Their Application - 2018_16
Official Title
Assessment of Novel Sound Changing Principles in Hearing Instruments to Determine Their Application
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
June 4, 2018 (Actual)
Primary Completion Date
July 31, 2018 (Actual)
Study Completion Date
July 31, 2018 (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
Data Monitoring Committee
No
5. Study Description
Brief Summary
An EEG study using continuous speech stimuli to assess neural language processing in a hearing impaired population. Participants listen to short radio excerpts in different Signal to Noise Ratios (SNR) and answer comprehension questions as well as listening effort questions. We assess the effect of different algorithms on neural language processing as well as subjective listening effort. Each participant hears 12 randomized segments of speech (about 4min long each) with different settings on their hearing aid (reference condition, noise reduction algorithm, beam forming algorithm). This will be a controlled, single blinded and randomized 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, Normal Hearing
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
44 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Hearing Aid without NR and BF
Arm Type
Active Comparator
Arm Description
Hearing Aid without Noise Reduction (NR) or beam forming (BF) enabled serves as reference condition.
Arm Title
Hearing Aid with NR
Arm Type
Experimental
Arm Description
Hearing Aid with Noise Reduction (NR) enabled.
Arm Title
Hearing Aid with BF
Arm Type
Experimental
Arm Description
Hearing Aid with beam forming (BF) enabled.
Intervention Type
Device
Intervention Name(s)
Hearing Aid without NR and BF
Intervention Description
Each participant will be fitted with the Noise Reduction (NR) and Beamforming (BF) disabled. Disabled means that no sound processing algorithm that removes noise from the speech signal is active.
Intervention Type
Device
Intervention Name(s)
Hearing Aid with NR
Intervention Description
Each participant will be fitted with the Noise Reduction (NR)(Sound Changing) program on the same hearing aid. Noise Reduction principle is a sound processing algorithm to remove noise from a speech signal to improve the speech intelligibility and comfort. The Noise Reduction is working spatially independent.
Intervention Type
Device
Intervention Name(s)
Hearing Aid with BF
Intervention Description
Each participant will be fitted with a beam forming program on the same hearing aid. Beam forming (BF) principle is a sound processing algorithm to remove noise from certain directions to improve the speech intelligibility and comfort.
Primary Outcome Measure Information:
Title
Electroencephalogram (EEG) data
Description
Neural language processing will be assessed through the EEG data collected while the participant is listening to running speech (neurophysiological data). Analysis of the brainstem response, cortical entrainment, N400 and alpha power are planned. EEG data is measured in Volt (mV), and entrainment data is analysed through coherence (frequency-based measure of correlation between the acoustic and the neural signal). N400 and alpha power are measured on the variance of mV over time.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Subjective Listening Effort rating
Description
The subjective Listening Effort rating will be assessed through self-reported individual listening effort on a scale from "extreme effort" to "no effort".
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy outer ear (without previous surgical procedures)
Ability to fill in a questionnaire conscientiously
Informed Consent as documented by signature
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
Limited ability to describe listening impressions/experiences and the use of the hearing aid
Inability to produce a reliable hearing test result
Massively limited dexterity
Known psychological problems
Known central hearing disorders
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juliane Raether
Organizational Affiliation
Sonova AG
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sonova AG
City
Stäfa
ZIP/Postal Code
8712
Country
Switzerland
12. IPD Sharing Statement
Plan to Share IPD
No
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Assessment of Novel Sound Changing Principles in Hearing Instruments to Determine Their Application - 2018_16
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