Assessment of Novel Sound Changing Principles in Hearing Instruments to Determine Their Application - 2018_12

Study Overview
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Brief Summary
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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

Official Title
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Assessment of Novel Sound Changing Principles in Hearing Instruments to Determine Their Application

Conditions
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Hearing Loss

Intervention / Treatment
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* Device: Hearing Aid without NR
* Device: Hearing Aid with NR_A
* Device: Hearing Aid with NR_B
* Device: Hearing Aid with NR_C


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy outer ear (without previous surgical procedures) Ability to fill in a questionnaire conscientiously Informed Consent as documented by signature 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 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Each participant will be treated with each sound changing principle (Noise Reduction principle (NR)) in a randomized order.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Hearing Aid without NR<br>Hearing Aid without Noise Reduction (NR) serves as reference condition. | Device: Hearing Aid without NR<br>* 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 vary in their parametrization to result in different degrees of noise suppression and good speech quality.<br>* Other names: NR: Noise Reduction;|
| Experimental: Hearing Aid with NR_A<br>NR_A: Noise Reduction principle A | Device: Hearing Aid with NR_A<br>* 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 vary in their parametrization to result in different degrees of noise suppression and good speech quality.<br>* Other names: NR_A: Noise Reduction principle A;|
| Experimental: Hearing Aid with NR_B<br>NR_B: Noise Reduction principle B. | Device: Hearing Aid with NR_B<br>* 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 vary in their parametrization to result in different degrees of noise suppression and good speech quality.<br>* Other names: NR_B: Noise Reduction principle B;|
| Experimental: Hearing Aid with NR_C<br>NR_C: Noise Reduction principle C. | Device: Hearing Aid with NR_C<br>* 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 vary in their parametrization to result in different degrees of noise suppression and good speech quality.<br>* Other names: NR_C: Noise Reduction principle C;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oldenburg sentence test in noise | 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. | 4 weeks | 
| Oldenburg sentence test & manual tracking task | 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. | 4 weeks | 
| Adaptive Categorial Listening Effort Scaling (ACALES) | 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. | 2 weeks | 
| Self-report form | 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. | One week |