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

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. These sound changing principles are enabled by respective 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 randomized active comparator clinical evaluation which will be conducted mono-centric at Sonova AG Headquarter based in Staefa.

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: Phonak Audéo L2M with Sound Processing Principle 1
* Device: Phonak Audéo L2M with Sound Processing Principle 2
* Device: Phonak Audéo L2M with Sound Processing Principle 3


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult hearing impaired persons (minimum age: 18 years) with and without experience with) hearing aids 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 medical device 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

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 sound principle 1, 2 and 3 in a crossover design.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Sound Processing Principle 1<br>Sound Processing Principle 1 will be applied in the hearing aid. | Device: Phonak Audéo L2M with Sound Processing Principle 1<br>* Compensation of a hearing loss with Sound Processing Principle 1.<br>|
| Experimental: Sound Processing Principle 2<br>Sound Processing Principle 2 will be applied in the hearing aid. | Device: Phonak Audéo L2M with Sound Processing Principle 2<br>* Compensation of a hearing loss with Sound Processing Principle 2.<br>|
| Experimental: Sound Processing Principle 3<br>Sound Processing Principle 3 will be applied in the hearing aid. | Device: Phonak Audéo L2M with Sound Processing Principle 3<br>* Compensation of a hearing loss with Sound Processing Principle 3.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Speech Intelligibility in Noise | The speech intelligibility in noise with the three different sound processing principles will be assessed with the aid of the Oldenburg Sentence Test. The result will be shown in dB (decibel) SRT (Speech Reception Threshold). | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sound Quality - Overall | The overall sound quality of sounds with the three different sound processing principles will be assessed with the aid of a questionnaire. The results are ratings on a numeric scale, ranging from 0 (bad) to 10 (excellent). | 16 weeks | 
| Loudness - Laboratory | The loudness of sounds with the three different sound processing principles will be assessed in laboratory with the aid of a MUSHRA (Multi-Stimulus Test with Hidden Reference and Anchor) test. The results are ratings on a numeric scale, ranging from 0 (very soft), 50 (just right) to 100 (very loud). | 8 weeks | 
| Loudness - Daily Life | The loudness of sounds with the three different sound processing principles will be assessed in daily life with the aid of a questionnaire. The results are ratings on a numeric scale, ranging from 0 (very soft) to 10 (very loud). | 16 weeks | 
| Clarity - Daily Life | The clarity of sounds with the three sound processing principles will be assessed with the aid of a questionnaire. The results are ratings on a numeric scale, ranging from 0 (very unclear) to 10 (very clear). | 16 weeks | 
| Preferred Sound Processing Principle | The preferred sound processing principle will be assessed with the aid of a questionnaire. The results will be a ranking, ranging from 1 (most preferred) to 3 (least preferred). | 16 weeks | 
| Naturalness - Daily Life | The sound quality with the three different sound processing principles will be assessed with the aid of a questionnaire. The results are ratings on a numeric scale, ranging from 0 (unnatural) to 10 (natural). | 16 weeks | 
| Localization - Daily Life | The ability to localize sounds with the three different sound processing principles will be assessed with the aid of a questionnaire. The results are ratings on a numeric scale, ranging from 0 (not at all locatable) to 10 (very well locatable). | 16 weeks | 
| Reverberation - Daily Life | The reverberation of sounds with the three different sound processing principles will be assessed with the aid of a questionnaire. The results are ratings on a numeric scale, ranging from 0 (not at all reverberant) to 10 (very reverberant). | 16 weeks | 
| Satisfaction - Overall in Daily Life | The overall satisfaction in daily life with the three different sound processing principles will be assessed with the aid of a questionnaire. The results are ratings on a numeric scale, ranging from 0 (very dissatisfied) to 10 (very satisfied). | 16 weeks |