Assessment of Novel Sound Changing Principles in Hearing Instruments to Determine Their Application - Sonova2018_31

Hearing Loss Clinical Trial

Official title:

Assessment of Novel Sound Changing Principles in Hearing Instruments to Determine Their Application

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03699735
• Other study ID #: Sonova2018_31
• Status: Completed
• Phase: N/A
• Start date: August 6, 2018
• Est. completion date: March 29, 2019

Study information

• Verified date: May 2019
• Source: Sonova AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A methodical evaluation of sound changing principles in CE-labelled Sonova brand hearing instruments (e.g. Phonak hearing instruments) is intended to be conducted on hearing impaired participants. These sound changing principles are enabled by respective hearing instrument technologies and hearing instrument algorithms. The aim of the study is to investigate and asses strength and weaknesses of these sound changing principles in terms of hearing performance to determine their application in hearing instruments (Phase of development). Objective laboratory measurements will be carried out. This will be a controlled, single blinded and randomised active comparator clinical evaluation which will be conducted mono centric at Sonova AG Headquarter based in Stäfa

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 29, 2019
• Est. primary completion date: December 20, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• Adult hearing impaired persons (minimum age: 18 years) with or without experience with hearing aids

• Sensorineural hearing loss (N4-N6 according to ISO 60118-15)

• Good written and spoken (Swiss) German language skills

• Healthy outer ear

• Informed Consent as documented by signature

• Symmetric hearing loss below 1000 Hz

Exclusion Criteria:

• Contraindications to the MD in this study, e.g. known hypersensitivity or allergy to the investigational product

• Limited mobility and not in the position to attend weekly appointments on study site

• Inability to produce a reliable hearing test result

• Known psychological problems

• Central hearing disorders

Related Conditions & MeSH terms

• Hearing Loss

Intervention

Device:
• Bolero B90-SP
Behind the ear Hearing device fitted with an individual ear mold to compensate a Hearing loss

Locations

Country	Name	City	State
Switzerland	Sonova AG	Stäfa	Zürich

Sponsors (1)

Lead Sponsor	Collaborator
Sonova AG

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Individual binaural Hearing abilities	Primary Outcome measurement is to measure the speech understanding in noise [SNR in dB] for the beam former principles A, B and C	2 weeks
Secondary	Speechunderstanding for different beam form principles	Secondary Outcome measurement is to measure individual binaural Hearing abilities with psycho acoustical test principles (Binaural inter aural Level difference [SNR in dB] and Binaural Masking Level Difference [SNR in dB] and speech test [Oldenburger Satztest in noise [SNR in dB]. Thereby, the correlation between psycho acoustical test results and speech test results will be analyzed.	2 weeks