Evaluation of Novel Noise Reduction Principles in Hearing Instruments

NCT05582408 | Completed

• 1 other identifier: SRF-382
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Hearing Loss

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

• Evaluation of subjectively different sound quality attributes/dimensions of the novel noise reduction algorithms versus standard noise reduction (Comparator)

  4 weeks

Study Arms (2)

Hearing Aid Standard NR1

ACTIVE COMPARATOR

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

Device: Measures of Standard Noise Reduction NR1

Novel Noise reduction principles

EXPERIMENTAL

Noise Reduction Principle NR2 and NR3.

Device: Measures of Noise Reduction Principle NR2; Device: Measure of Noise Reduction Principle NR3

Interventions

Measures of Standard Noise Reduction NR1 DEVICE

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

Hearing Aid Standard NR1

Measures of Noise Reduction Principle NR2 DEVICE

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

Novel Noise reduction principles

Measure of Noise Reduction Principle NR3 DEVICE

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

Novel Noise reduction principles

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Sonova AG: lead

Study Sites (1)

Hörzentrum Oldenburg gGmbH

Oldenburg, Lower Saxony, 26129, Germany

Location

MeSH Terms

Conditions

Hearing Loss

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Marlene Zippel

  Sonova AG

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2022
• First Posted: October 17, 2022
• Study Start: September 12, 2022
• Primary Completion: October 25, 2022
• Study Completion: November 1, 2022
• Last Updated: November 17, 2022

Record last verified: 2022-09

Locations

DE (1)