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

Primary Purpose

Hearing Loss, Bilateral or Unilateral

Status
Unknown status
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
hearing aid (MD class IIa) - ITE, BTE, RIC
Sponsored by
Phonak AG, Switzerland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Hearing Loss, Bilateral or Unilateral

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Sonova AG

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Hearing Device Type A

Hearing Device Type B

Arm Description

In the ear (ITE) hearing aid, 1-3 weeks wearing

In the ear (ITE) hearing aid, 1-3 weeks wearing

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Subjective rating of the intervention via questionnaire.
Ordinal scale

Full Information

First Posted
August 19, 2015
Last Updated
August 28, 2019
Sponsor
Phonak AG, Switzerland
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1. Study Identification

Unique Protocol Identification Number
NCT02545569
Brief Title
Evaluation of New Custom Made Hearing Product Technology and Shell Modification
Acronym
CPS
Official Title
Evaluation of New Custom Made Hearing Product Technology and Shell Modification
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 6, 2020 (Anticipated)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Phonak AG, Switzerland

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss, Bilateral or Unilateral

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hearing Device Type A
Arm Type
Active Comparator
Arm Description
In the ear (ITE) hearing aid, 1-3 weeks wearing
Arm Title
Hearing Device Type B
Arm Type
Experimental
Arm Description
In the ear (ITE) hearing aid, 1-3 weeks wearing
Intervention Type
Device
Intervention Name(s)
hearing aid (MD class IIa) - ITE, BTE, RIC
Other Intervention Name(s)
hearing accessory (MD class I) - DM systems, FM systems, remote control
Intervention Description
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.
Primary Outcome Measure Information:
Title
Objective measurement of speech intelligibility related to the intervention.
Description
SNR (speech to noise ratio) in decibel.
Time Frame
5 years
Title
Objective measurement of the transfer function related to the intervention.
Description
REM (real ear measurement) in decibel.
Time Frame
5 years
Title
Objective measurement from the position of the outer ear related to the test subject.
Description
Measurement in degree.
Time Frame
5 years
Title
Objective measurement from the size of the outer ear related to the test subject.
Description
Measurement in micron.
Time Frame
5 years
Title
Objective measurement of humidity in the ear canal related to the test subject and the intervention.
Description
Measurement in percent.
Time Frame
5 years
Title
Objective measurement of temperature in the ear canal related to the test subject and the intervention.
Description
Measurement in degree centigrade.
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Subjective rating of the intervention via questionnaire.
Description
Ordinal scale
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jana-Kosima Schwarzlos, B.Sc.
Phone
+41 58 928 0101
Email
JanaKosima.Schwarzlos@sonova.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jana-Kosima Schwarzlos, B.Sc.
Organizational Affiliation
Switzerland, Sonova AG, CH-8712 Staefa, Zurich
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sonova AG
City
Stäfa
State/Province
Zürich
ZIP/Postal Code
8712
Country
Switzerland
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jana-Kosima Schwarzlos
Phone
0041 58 928 0101
Email
JanaKosima.Schwarzlos@sonova.com

12. IPD Sharing Statement

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Evaluation of New Custom Made Hearing Product Technology and Shell Modification

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