Back to resultsEvaluation of Novel Noise Reduction Principles in Hearing Instruments
Primary Purpose
Hearing Loss
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Measures of Standard Noise Reduction NR1
Measures of Noise Reduction Principle NR2
Measure of Noise Reduction Principle NR3
Sponsored by
About this trial
This is an interventional treatment trial for Hearing Loss
Eligibility Criteria
Inclusion Criteria:
- Minimum age for men: 18 years, minimum age for wom-en: 64 years, hearing aid users,
- Written and spoken German,
- Hearing loss range: N3-N4 Hearing loss (sensorineural)
- Healthy outer ear,
- Ability to understand and follow the instruction of the in-vestigator
- Informed consent as documented by signature.
Exclusion Criteria:
- Clinical contraindications 1) hearing loss is not within the fitting range of the hearing aid, 2) acute tinnitus, 3) de-formity of the ear (closed ear canal or absence of pinna), and 4) neural hearing loss i.e., retro-cochlear pathologies such as absent / non-viable auditory nerve
- Pregnant or breastfeeding women
- Age >85 years
- known hypersensitivity or allergy,
- limited mobility and not able to attend the appointments
Sites / Locations
- Hörzentrum Oldenburg gGmbH
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Hearing Aid Standard NR1
Novel Noise reduction principles
Arm Description
Hearing Aid with standard Noise Reduction (NR1) serves as reference condition.
Noise Reduction Principle NR2 and NR3.
Outcomes
Primary Outcome Measures
Difference in speech reception thresholds (SRTs) in noise between novel noise reduction algorithm (NR2) and the standard noise reduction (NR1; Comparator)
SRTs are measured with the OLSA test.
Secondary Outcome Measures
Evaluation whether the novel noise reduction algorithm (NR3) provides different SRTs in noisy situation with speech from front compared to the current implemented "standard noise reduction" (NR1; Comparator)
SRTs are measured with the OLSA test.
Evaluation of subjectively different sound quality attributes/dimensions of the novel noise reduction algorithms versus standard noise reduction (Comparator)
The sound quality ratings will be assessed with the aid of a Multi-Stimulus Test.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05582408
Brief Title
Evaluation of Novel Noise Reduction Principles in Hearing Instruments
Official Title
Evaluation of Novel Noise Reduction Principles in Hearing Instruments to Determine Their Applicability.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
September 12, 2022 (Actual)
Primary Completion Date
October 25, 2022 (Actual)
Study Completion Date
November 1, 2022 (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
In the study, the speech intelligibility in noise (Outcome) between a novel noise reduction algorithm (Intervention) versus the standard noise reduction (Comparator) will be tested in adults with a N3-N4 hearing loss (Population) using streamed signals via hearing aids.
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
Single Group Assignment
Masking
ParticipantCare Provider
Allocation
Non-Randomized
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Hearing Aid Standard NR1
Arm Type
Active Comparator
Arm Description
Hearing Aid with standard Noise Reduction (NR1) serves as reference condition.
Arm Title
Novel Noise reduction principles
Arm Type
Experimental
Arm Description
Noise Reduction Principle NR2 and NR3.
Intervention Type
Device
Intervention Name(s)
Measures of Standard Noise Reduction NR1
Intervention Description
Each participant will be fitted with the Standard Noise Reduction (NR1)
Intervention Type
Device
Intervention Name(s)
Measures of Noise Reduction Principle NR2
Intervention Description
Each participant will be fitted with the novel Noise Reduction principle NR2 on the same hearing aid
Intervention Type
Device
Intervention Name(s)
Measure of Noise Reduction Principle NR3
Intervention Description
Each participant will be fitted with the novel Noise Reduction principle NR3 on the same hearing aid
Primary Outcome Measure Information:
Title
Difference in speech reception thresholds (SRTs) in noise between novel noise reduction algorithm (NR2) and the standard noise reduction (NR1; Comparator)
Description
SRTs are measured with the OLSA test.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Evaluation whether the novel noise reduction algorithm (NR3) provides different SRTs in noisy situation with speech from front compared to the current implemented "standard noise reduction" (NR1; Comparator)
Description
SRTs are measured with the OLSA test.
Time Frame
4 weeks
Title
Evaluation of subjectively different sound quality attributes/dimensions of the novel noise reduction algorithms versus standard noise reduction (Comparator)
Description
The sound quality ratings will be assessed with the aid of a Multi-Stimulus Test.
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Minimum age for men: 18 years, minimum age for wom-en: 64 years, hearing aid users,
Written and spoken German,
Hearing loss range: N3-N4 Hearing loss (sensorineural)
Healthy outer ear,
Ability to understand and follow the instruction of the in-vestigator
Informed consent as documented by signature.
Exclusion Criteria:
Clinical contraindications 1) hearing loss is not within the fitting range of the hearing aid, 2) acute tinnitus, 3) de-formity of the ear (closed ear canal or absence of pinna), and 4) neural hearing loss i.e., retro-cochlear pathologies such as absent / non-viable auditory nerve
Pregnant or breastfeeding women
Age >85 years
known hypersensitivity or allergy,
limited mobility and not able to attend the appointments
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marlene Zippel
Organizational Affiliation
Sonova AG
Official's Role
Study Director
Facility Information:
Facility Name
Hörzentrum Oldenburg gGmbH
City
Oldenburg
State/Province
Niedersachsen
ZIP/Postal Code
26129
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Evaluation of Novel Noise Reduction Principles in Hearing Instruments
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