Evaluation of Novel Noise Reduction Principles in Hearing Instruments

Hearing Loss Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05582408
• Other study ID #: SRF-382
• Status: Completed
• Phase: N/A
• Start date: September 12, 2022
• Est. completion date: November 1, 2022

Study information

• Verified date: September 2022
• Source: Sonova AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: November 1, 2022
• Est. primary completion date: October 25, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Hearing Loss

Intervention

Device:
• Measures of Standard Noise Reduction NR1
Each participant will be fitted with the Standard Noise Reduction (NR1)
• Measures of Noise Reduction Principle NR2
Each participant will be fitted with the novel Noise Reduction principle NR2 on the same hearing aid
• Measure of Noise Reduction Principle NR3
Each participant will be fitted with the novel Noise Reduction principle NR3 on the same hearing aid

Locations

Country	Name	City	State
Germany	Hörzentrum Oldenburg gGmbH	Oldenburg	Niedersachsen

Sponsors (1)

Lead Sponsor	Collaborator
Sonova AG

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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