Assessment of Novel Sound Changing Principles in Hearing Instruments to Determine Their Application - Sonova2018_31
- Conditions
- Hearing Loss
- Interventions
- Device: Bolero B90-SP
- Registration Number
- NCT03699735
- Lead Sponsor
- Sonova AG
- Brief 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Hearing Aid with beam form principle_C Bolero B90-SP Device: Hearing Aid beam former principle_C. Each participant will be fitted with the 3 different beam former (directionality change) principles on the same hearing aid, saved to 3 manual programs. Beam former principle is a sound processing algorithm to focus to a target source in a noisy situation to improve the speech intelligibility and comfort. The experimental conditions vary in their parametrization to result in different degrees of beam forming and good speech quality. Hearing Aid with beam form principle_A Bolero B90-SP Device: Hearing Aid beam former principle_A (simulation of real ear condition). Each participant will be fitted with the 3 different beam former (directionality change) principles on the same hearing aid, saved to 3 manual programs. Beam former principle is a sound processing algorithm to focus to a target source in a noisy situation to improve the speech intelligibility and comfort. The experimental conditions vary in their parametrization to result in different degrees of beam forming and good speech quality. Hearing Aid with beam form principle_B Bolero B90-SP Device: Hearing Aid beam former principle_B. Each participant will be fitted with the 3 different beam former (directionality change) principles on the same hearing aid, saved to 3 manual programs. Beam former principle is a sound processing algorithm to focus to a target source in a noisy situation to improve the speech intelligibility and comfort. The experimental conditions vary in their parametrization to result in different degrees of beam forming and good speech quality.
- Primary Outcome Measures
Name Time Method Individual binaural Hearing abilities 2 weeks Primary Outcome measurement is to measure the speech understanding in noise \[SNR in dB\] for the beam former principles A, B and C
- Secondary Outcome Measures
Name Time Method Speechunderstanding for different beam form principles 2 weeks 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.
Trial Locations
- Locations (1)
Sonova AG
🇨🇭Stäfa, Zürich, Switzerland