Hearing Loss
Conditions
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
Interventions
DEVICEBolero B90-SP
Behind the ear Hearing device fitted with an individual ear mold to compensate a Hearing loss
Sponsors
Sonova AG
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Single (Participant)
Intervention model description
Crossover Assignment Each participant will be treated with each test condition in a randomized order.
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Switzerland
Outcome results
None listed