Evaluation of New Custom Made Hearing Product Technology and Shell Modification (CPS)

August 28, 2019 updated by: Phonak AG, Switzerland
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Hearing Device Type A
In the ear (ITE) hearing aid, 1-3 weeks wearing
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.
Other Names:
  • hearing accessory (MD class I) - DM systems, FM systems, remote control
Experimental: Hearing Device Type B
In the ear (ITE) hearing aid, 1-3 weeks wearing
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.
Other Names:
  • hearing accessory (MD class I) - DM systems, FM systems, remote control

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Phonak AG, Switzerland

Investigators

  • Principal Investigator: Jana-Kosima Schwarzlos, B.Sc., Switzerland, Sonova AG, CH-8712 Staefa, Zurich

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 6, 2020

Primary Completion (Anticipated)

December 1, 2020

Study Completion (Anticipated)

December 1, 2020

Study Registration Dates

First Submitted

August 19, 2015

First Submitted That Met QC Criteria

September 7, 2015

First Posted (Estimate)

September 10, 2015

Study Record Updates

Last Update Posted (Actual)

August 30, 2019

Last Update Submitted That Met QC Criteria

August 28, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KEK-ZH-Nr. 2014-0459

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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