Evaluation of Novel Noise Reduction Principles in Hearing Instruments

Sonova

Status: Completed

Conditions: Hearing Loss

Treatments: Device: Measure of Noise Reduction Principle NR3; Device: Measures of Noise Reduction Principle NR2; Device: Measures of Standard Noise Reduction NR1

Study type: Interventional

Funder types: Industry

Identifiers

NCT05582408

SRF-382

Details and patient eligibility

About

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.

Enrollment: 26 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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26 participants in 2 patient groups

Hearing Aid Standard NR1

Active Comparator group

Description:

Hearing Aid with standard Noise Reduction (NR1) serves as reference condition.

Treatment:

Device: Measures of Standard Noise Reduction NR1

Novel Noise reduction principles

Experimental group

Description:

Noise Reduction Principle NR2 and NR3.

Treatment:

Device: Measures of Noise Reduction Principle NR2

Device: Measure of Noise Reduction Principle NR3