Evaluation of Novel Noise Reduction Principles in Hearing Instruments

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

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 Overview

• Status: Completed
• Conditions: Hearing Loss
• Intervention / Treatment: Device: Measures of Standard Noise Reduction NR1; Device: Measures of Noise Reduction Principle NR2; Device: Measure of Noise Reduction Principle NR3

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Niedersachsen
    • Oldenburg, Niedersachsen, Germany, 26129
      • Hörzentrum Oldenburg gGmbH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Sonova AG
• Investigators: Study Director: Marlene Zippel, Sonova AG

Study record dates

Study Major Dates

• Study Start (Actual): September 12, 2022
• Primary Completion (Actual): October 25, 2022
• Study Completion (Actual): November 1, 2022

Study Registration Dates

• First Submitted: October 12, 2022
• First Submitted That Met QC Criteria: October 12, 2022
• First Posted (Actual): October 17, 2022

Study Record Updates

• Last Update Posted (Actual): November 17, 2022
• Last Update Submitted That Met QC Criteria: November 16, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Hearing Loss
• Other Study ID Numbers: SRF-382

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No