Assessment of Novel Sound Changing Principles in Hearing Instruments to Determine Their Application - 2018_12
- Conditions
- Hearing Loss
- Interventions
- Device: Hearing Aid without NRDevice: Hearing Aid with NR_ADevice: Hearing Aid with NR_BDevice: Hearing Aid with NR_C
- Registration Number
- NCT03554577
- Lead Sponsor
- Sonova AG
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 15
- Healthy outer ear (without previous surgical procedures)
- Ability to fill in a questionnaire conscientiously
- Informed Consent as documented by signature
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Hearing Aid without NR Hearing Aid without NR Hearing Aid without Noise Reduction (NR) serves as reference condition. Hearing Aid with NR_A Hearing Aid with NR_A NR_A: Noise Reduction principle A Hearing Aid with NR_B Hearing Aid with NR_B NR_B: Noise Reduction principle B. Hearing Aid with NR_C Hearing Aid with NR_C NR_C: Noise Reduction principle C.
- Primary Outcome Measures
Name Time Method Sound quality ratings 4 weeks 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.
- Secondary Outcome Measures
Name Time Method Oldenburg sentence test in noise 4 weeks The data, serving as secondary outcome is a Signal to noise ratio (SNR) in decibel (dB) where a 50% speech reception threshold is reached. This outcome measurement will be carried out in the laboratory.
Oldenburg sentence test & manual tracking task 4 weeks A dual task paradigm will be used in which the Oldenburg Sentence test in noise will be administered as a primary task, and the subject will manually track a point on a computerised elliptical track as a secondary task. The aim is to recall as many words from the presented sentence at a predefined SNR and track the point as accurately as possible at the same time. The SNR is set as the level at which a subject reaches a speech reception threshold of 80-90%. The data derived, serving as a secondary outcome measure, are a \[%\] of time on target and distance error from the target.
Adaptive Categorial Listening Effort Scaling (ACALES) 2 weeks The ACALES procedure determines self-reported individual listening effort on a scale from "extreme effort" to "no effort" within a signal-to-noise ratio range that corresponds to individual subject perceptions.
The data, serving as a secondary outcome, are a set of points on a categorial scale (subjectively perceived listening effort) as a function of different SNRs.Self-report form One week A qualitative questionnaire with predefined questions and comment sections to gather information on individual perceptions regarding the comparison of two different hearing programs during different laboratory-based acoustic scenes. For details of the hearing aid settings, see study arms. The data collected from this questionnaire are scores on a continuous rating scale ranging from "hearing program A is much worse than hearing program B" to "hearing program B is much better than hearing program A" and any subjective comments given.
Trial Locations
- Locations (1)
Sonova AG
🇨🇭Stäfa, Switzerland