Evaluation of Novel Noise Reduction Principles in Hearing Instruments

Sonova AG26 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Hearing Loss

Interventions

Measures of Standard Noise Reduction NR1DEVICE

Each participant will be fitted with the Standard Noise Reduction (NR1)

Measures of Noise Reduction Principle NR2DEVICE

Each participant will be fitted with the novel Noise Reduction principle NR2 on the same hearing aid

Measure of Noise Reduction Principle NR3DEVICE

Each participant will be fitted with the novel Noise Reduction principle NR3 on the same hearing aid

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (1)

Hörzentrum Oldenburg gGmbH

Oldenburg, Lower Saxony, Germany

Outcomes

Primary Outcomes

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.

Time frame: 4 weeks

Secondary Outcomes

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.

Time frame: 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.

Time frame: 4 weeks

Data from ClinicalTrials.gov

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