Evaluation of Novel Noise Reduction Principles in Hearing Instruments

Not Applicable

Completed

• Conditions: Hearing Loss
• Interventions: Device: Measures of Noise Reduction Principle NR2; Device: Measures of Standard Noise Reduction NR1; Device: Measure of Noise Reduction Principle NR3

• Registration Number: NCT05582408
• Lead Sponsor: Sonova AG

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-09
• Study Start: 2022-09-12
• Study First Submitted: 2022-10-12
• Study First Submitted QC: 2022-10-12
• Study First Posted: 2022-10-17
• Primary Completion: 2022-10-25
• Study Completion: 2022-11-01
• Last Update Submitted: 2022-11-16
• Last Update Posted: 2022-11-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Novel Noise reduction principles	Measures of Noise Reduction Principle NR2	Noise Reduction Principle NR2 and NR3.
Novel Noise reduction principles	Measure of Noise Reduction Principle NR3	Noise Reduction Principle NR2 and NR3.
Hearing Aid Standard NR1	Measures of Standard Noise Reduction NR1	Hearing Aid with standard Noise Reduction (NR1) serves as reference condition.

Primary Outcome Measures

Name	Time	Method
Difference in speech reception thresholds (SRTs) in noise between novel noise reduction algorithm (NR2) and the standard noise reduction (NR1; Comparator)	4 weeks	SRTs are measured with the OLSA test.

Secondary Outcome Measures

Name	Time	Method
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)	4 weeks	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)	4 weeks	The sound quality ratings will be assessed with the aid of a Multi-Stimulus Test.

Trial Locations

Locations (1)

Hörzentrum Oldenburg gGmbH; 🇩🇪 Oldenburg, Niedersachsen, Germany