Assessment of Novel Sound Changing Principles in Hearing Instruments to Determine Their Application - Sonova2018_31
1 other identifier
interventional
30
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2018
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 6, 2018
CompletedFirst Submitted
Initial submission to the registry
October 5, 2018
CompletedFirst Posted
Study publicly available on registry
October 9, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 20, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
March 29, 2019
CompletedMay 6, 2019
May 1, 2019
5 months
October 5, 2018
May 3, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Speechunderstanding for different beam form principles
2 weeks
Study Arms (3)
Hearing Aid with beam form principle_A
ACTIVE COMPARATORDevice: 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
EXPERIMENTALDevice: 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.
Hearing Aid with beam form principle_C
EXPERIMENTALDevice: 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.
Interventions
Behind the ear Hearing device fitted with an individual ear mold to compensate a Hearing loss
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sonova AGlead
Study Sites (1)
Sonova AG
Stäfa, Canton of Zurich, 8712, Switzerland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- Single (Participant)
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 5, 2018
First Posted
October 9, 2018
Study Start
August 6, 2018
Primary Completion
December 20, 2018
Study Completion
March 29, 2019
Last Updated
May 6, 2019
Record last verified: 2019-05