Evaluation of Novel Noise Reduction Principles in Hearing Instruments

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation of Novel Noise Reduction Principles in Hearing Instruments to Determine Their Applicability.

Conditions
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Hearing Loss

Intervention / Treatment
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* Device: Measures of Standard Noise Reduction NR1
* Device: Measures of Noise Reduction Principle NR2
* Device: Measure of Noise Reduction Principle NR3


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Hearing Aid Standard NR1<br>Hearing Aid with standard Noise Reduction (NR1) serves as reference condition. | Device: Measures of Standard Noise Reduction NR1<br>* Each participant will be fitted with the Standard Noise Reduction (NR1)<br>|
| Experimental: Novel Noise reduction principles<br>Noise Reduction Principle NR2 and NR3. | Device: Measures of Noise Reduction Principle NR2<br>* Each participant will be fitted with the novel Noise Reduction principle NR2 on the same hearing aid<br>Device: Measure of Noise Reduction Principle NR3<br>* Each participant will be fitted with the novel Noise Reduction principle NR3 on the same hearing aid<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 4 weeks | 
| 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. | 4 weeks |