Evaluation of New Custom Made Hearing Product Technology and Shell Modification

Hearing Loss, Bilateral or Unilateral Clinical Trial

— CPS  

Official title:

Evaluation of New Custom Made Hearing Product Technology and Shell Modification

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02545569
• Other study ID #: KEK-ZH-Nr. 2014-0459
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 6, 2020
• Est. completion date: December 2020

Study information

• Verified date: August 2019
• Source: Phonak AG, Switzerland
• Contact: Jana-Kosima Schwarzlos, B.Sc.
• Phone: +41 58 928 0101
• Email: JanaKosima.Schwarzlos[@]sonova.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 25
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Hearing Loss
• Hearing Loss, Bilateral
• Hearing Loss, Bilateral or Unilateral

Intervention

Device:
• hearing 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.

Locations

Country	Name	City	State
Switzerland	Sonova AG	Stäfa	Zürich

Sponsors (1)

Lead Sponsor	Collaborator
Phonak AG, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective measurement of speech intelligibility related to the intervention.	SNR (speech to noise ratio) in decibel.	5 years
Primary	Objective measurement of the transfer function related to the intervention.	REM (real ear measurement) in decibel.	5 years
Primary	Objective measurement from the position of the outer ear related to the test subject.	Measurement in degree.	5 years
Primary	Objective measurement from the size of the outer ear related to the test subject.	Measurement in micron.	5 years
Primary	Objective measurement of humidity in the ear canal related to the test subject and the intervention.	Measurement in percent.	5 years
Primary	Objective measurement of temperature in the ear canal related to the test subject and the intervention.	Measurement in degree centigrade.	5 years
Secondary	Subjective rating of the intervention via questionnaire.	Ordinal scale	5 years