Evaluation of New Custom Made Hearing Product Technology and Shell Modification

Study Overview
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Brief Summary
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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
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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.

Official Title
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Evaluation of New Custom Made Hearing Product Technology and Shell Modification

Conditions
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Hearing Loss, Bilateral or Unilateral

Intervention / Treatment
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* Device: hearing aid (MD class IIa) - ITE, BTE, RIC


Participation Criteria
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Eligibility Criteria
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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

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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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Hearing Device Type A<br>In the ear (ITE) hearing aid, 1-3 weeks wearing | Device: hearing aid (MD class IIa) - ITE, BTE, RIC<br>* 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.<br>* Other names: hearing accessory (MD class I) - DM systems, FM systems, remote control;|
| Experimental: Hearing Device Type B<br>In the ear (ITE) hearing aid, 1-3 weeks wearing | Device: hearing aid (MD class IIa) - ITE, BTE, RIC<br>* 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.<br>* Other names: hearing accessory (MD class I) - DM systems, FM systems, remote control;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective measurement of speech intelligibility related to the intervention. | SNR (speech to noise ratio) in decibel. | 5 years | 
| Objective measurement of the transfer function related to the intervention. | REM (real ear measurement) in decibel. | 5 years | 
| Objective measurement from the position of the outer ear related to the test subject. | Measurement in degree. | 5 years | 
| Objective measurement from the size of the outer ear related to the test subject. | Measurement in micron. | 5 years | 
| Objective measurement of humidity in the ear canal related to the test subject and the intervention. | Measurement in percent. | 5 years | 
| Objective measurement of temperature in the ear canal related to the test subject and the intervention. | Measurement in degree centigrade. | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective rating of the intervention via questionnaire. | Ordinal scale | 5 years |