Evaluation of New Custom Made Hearing Product Technology and Shell Modification

NCT ID: NCT02545569

Last Updated: 2019-08-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-06

Study Completion Date

2020-12-31

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.

Conditions

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Hearing Loss, Bilateral or Unilateral

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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Hearing Device Type A

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

Group Type ACTIVE_COMPARATOR

hearing aid (MD class IIa) - ITE, BTE, RIC

Intervention Type DEVICE

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.

Hearing Device Type B

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

Group Type EXPERIMENTAL

hearing aid (MD class IIa) - ITE, BTE, RIC

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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hearing accessory (MD class I) - DM systems, FM systems, remote control

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Phonak AG, Switzerland

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jana-Kosima Schwarzlos, B.Sc.

Role: PRINCIPAL_INVESTIGATOR

Switzerland, Sonova AG, CH-8712 Staefa, Zurich

Locations

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Sonova AG

Stäfa, Canton of Zurich, Switzerland

Site Status

Countries

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Switzerland

Central Contacts

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Jana-Kosima Schwarzlos, B.Sc.

Role: CONTACT

+41 58 928 0101

Facility Contacts

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Jana-Kosima Schwarzlos

Role: primary

0041 58 928 0101

Other Identifiers

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KEK-ZH-Nr. 2014-0459

Identifier Type: -

Identifier Source: org_study_id

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