Hearing Loss, Bilateral or Unilateral
Conditions
Brief summary
The purpose of this evaluation is to receive the greatest benefit of new custom made hearing product technology and shell modification for the end customer and to continual improve the custom made hearing products.
Detailed description
This is a controlled, single blinded comparative study which is conducted monocentric at Phonak Headquarters in Staefa. The purpose of the studies is to evaluate the strengths and weaknesses of new custom product development in comparison to existing/old products. The results should promote the custom product development, to provide a maximum of benefit and wearing comfort to the hearing aid user.
Interventions
DEVICEhearing aid (MD class IIa) - ITE, BTE, RIC
Hearing aid means any wearable instrument or device designed for, offered for the purpose of, or represented as aiding persons with or compensating for, impaired hearing.
Sponsors
Phonak AG, Switzerland
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
Yes
Inclusion criteria
* Only adult participants between 18 and 99 years * lnformed Consent as documented by signature (Appendix lnformed Consent Form) * Ability to fill in a questionnaire conscientious * Healthy outer ear (w/o previous surgical procedures)
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 * lnability to produce a reliable hearing test result when pure tone audiometry is attempted by the audiologist * Massively limited dexterity * Psychological problems * Central hearing problems
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective measurement from the position of the outer ear related to the test subject. | 5 years | Measurement in degree. |
| Objective measurement of speech intelligibility related to the intervention. | 5 years | SNR (speech to noise ratio) in decibel. |
| Objective measurement of the transfer function related to the intervention. | 5 years | REM (real ear measurement) in decibel. |
| Objective measurement of temperature in the ear canal related to the test subject and the intervention. | 5 years | Measurement in degree centigrade. |
| Objective measurement from the size of the outer ear related to the test subject. | 5 years | Measurement in micron. |
| Objective measurement of humidity in the ear canal related to the test subject and the intervention. | 5 years | Measurement in percent. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subjective rating of the intervention via questionnaire. | 5 years | Ordinal scale |
Countries
Switzerland
Contacts
Primary ContactJana-Kosima Schwarzlos, B.Sc.
Outcome results
None listed