Evaluation of New Custom Made Hearing Product Technology and Shell Modification

Not Applicable

• Conditions: Hearing Loss, Bilateral or Unilateral
• Interventions: Device: hearing aid (MD class IIa) - ITE, BTE, RIC

• Registration Number: NCT02545569
• Lead Sponsor: Phonak AG, Switzerland

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.

Study Timeline

• Study First Submitted: 2015-08-19
• Study First Submitted QC: 2015-09-07
• Study First Posted: 2015-09-10
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-28
• Last Update Posted: 2019-08-30
• Study Start: 2020-01-06
• Primary Completion: 2020-12
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Hearing Device Type A	hearing aid (MD class IIa) - ITE, BTE, RIC	In the ear (ITE) hearing aid, 1-3 weeks wearing
Hearing Device Type B	hearing aid (MD class IIa) - ITE, BTE, RIC	In the ear (ITE) hearing aid, 1-3 weeks wearing

Primary Outcome Measures

Name	Time	Method
Objective measurement from the position of the outer ear related to the test subject.	5 years	Measurement in degree.
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.
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.

Secondary Outcome Measures

Name	Time	Method
Subjective rating of the intervention via questionnaire.	5 years	Ordinal scale

Trial Locations

Locations (1)

Sonova AG; 🇨🇭 Stäfa, Zürich, Switzerland