Assessment of Novel Sound Changing Principles in Hearing Instruments to Determine Their Application - 2019_20
1 other identifier
interventional
22
1 country
1
Brief Summary
A methodical evaluation of novel 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 novel sound changing principles in terms of hearing performance to determine their application in hearing instruments (Phase of development). Both, objective laboratory measurements as well as subjective evaluations in real life environment 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 Jun 2019
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
June 3, 2019
CompletedFirst Submitted
Initial submission to the registry
June 20, 2019
CompletedFirst Posted
Study publicly available on registry
July 15, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 19, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 16, 2019
CompletedOctober 11, 2019
October 1, 2019
3 months
June 20, 2019
October 10, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
sound quality ratings
The sound quality ratings will be assessed with the aid of a Multi-Stimulus Test. The data, serving as the primary outcome measure, are collected in the laboratory and will use a continuous rating scale. The scale ranges from 0 "very bad" to 100 "very good" in increments of 1.
4 weeks
Secondary Outcomes (4)
Oldenburg sentence test & reaction time task
3 weeks
Oldenburg Sentence test (Olsa)
4 weeks
Adaptive Categorial Listening Effort Scaling (ACALES)
3 weeks
qualitative interview form
3 weeks
Other Outcomes (2)
Non-verbal Trail Making Test A & B
1 week
color-word-interference test by J.R.Stroop
1 week
Study Arms (4)
Hearing Aid standard NR_1
ACTIVE COMPARATORHearing Aid with standard Noise Reduction (NR) serves as reference condition.
Hearing Aid with NR_2
EXPERIMENTALNR\_2: Noise Reduction principle 2
Hearing Aid with NR_3
EXPERIMENTALNR\_3: Noise Reduction principle 3
Hearing Aid with NR_4
EXPERIMENTALNR\_4: Noise Reduction principle 4
Interventions
Hearing Aid with standard Noise Reduction (NR) Each participant will be fitted with the 4 different Noise Reduction (Sound Changing) principles on the same hearing aid, saved to 4 manual programs (ensures exact same hearing loss compensation for each intervention). Noise Reduction principle is a sound processing algorithm to remove noise from a speech signal to improve the speech intelligibility and comfort. The active comparator condition is the state of the art Noise Reduction principle.
Each participant will be fitted with the 4 different Noise Reduction (Sound Changing) principles on the same hearing aid, saved to 4 manual programs. Noise Reduction principle is a sound processing algorithm to remove noise from a speech signal to improve the speech intelligibility and comfort. The experimental conditions (novel NR principle) vary in their parametrization to result in different degrees of noise suppression and good speech quality.
Each participant will be fitted with the 4 different Noise Reduction (Sound Changing) principles on the same hearing aid, saved to 4 manual programs. Noise Reduction principle is a sound processing algorithm to remove noise from a speech signal to improve the speech intelligibility and comfort. The experimental conditions (novel NR principle) vary in their parametrization to result in different degrees of noise suppression and good speech quality.
Each participant will be fitted with the 4 different Noise Reduction (Sound Changing) principles on the same hearing aid, saved to 4 manual programs. Noise Reduction principle is a sound processing algorithm to remove noise from a speech signal to improve the speech intelligibility and comfort. This experimental condition combines standard NR and novel NR principle to result in different degrees of noise suppression and good speech quality.
Eligibility Criteria
You may qualify if:
- Healthy outer ear (without previous surgical procedures)
- Ability to fill in a questionnaire conscientiously
- Informed Consent as documented by signature
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
- Limited ability to describe listening impressions/experiences and the use of the hearing aid
- Inability to produce a reliable hearing test result
- Massively limited dexterity
- Known psychological problems
- Known central hearing disorders
- colour blinded
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sonova AGlead
Study Sites (1)
Sonova AG
Stäfa, 8712, Switzerland
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Juliane Raether
Sonova AG
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 20, 2019
First Posted
July 15, 2019
Study Start
June 3, 2019
Primary Completion
August 19, 2019
Study Completion
September 16, 2019
Last Updated
October 11, 2019
Record last verified: 2019-10
Data Sharing
- IPD Sharing
- Will not share