Hearing Loss
Conditions
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. 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.
Interventions
DEVICEPhonak Audéo L2M with Sound Processing Principle 1
Compensation of a hearing loss with Sound Processing Principle 1.
DEVICEPhonak Audéo L2M with Sound Processing Principle 2
Compensation of a hearing loss with Sound Processing Principle 2.
DEVICEPhonak Audéo L2M with Sound Processing Principle 3
Compensation of a hearing loss with Sound Processing Principle 3.
Sponsors
Sonova AG
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
The participant's will not know which intervention will be applied.
Intervention model description
Each participant will be treated with sound principle 1, 2 and 3 in a crossover design.
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Speech Intelligibility in Noise | 4 weeks | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clarity - Daily Life | 16 weeks | 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). |
| Preferred Sound Processing Principle | 16 weeks | 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). |
| Sound Quality - Overall | 16 weeks | 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). |
| Loudness - Laboratory | 8 weeks | 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). |
| Naturalness - Daily Life | 16 weeks | 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). |
| Localization - Daily Life | 16 weeks | 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). |
| Reverberation - Daily Life | 16 weeks | 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). |
| Satisfaction - Overall in Daily Life | 16 weeks | 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). |
| Loudness - Daily Life | 16 weeks | 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). |
Countries
Switzerland
Outcome results
None listed