Quality Control of CE-Certified Phonak Hearing Aids - 2018_07

September 14, 2018 updated by: Sonova AG
Phonak Hearing Systems pass through different development and study stages. At an early stage, feasibility studies are conducted to investigate new algorithms, features and functions in an isolated manner. If the benefit is proven, their performance is then investigated regarding interdependency between all available algorithms, features and functions running in parallel in a hearing aid (pivotal/pre-validation studies) and, as a result, they get optimized. Afterwards, and prior to product launch, the Phonak Hearing Systems undergo a final quality control in terms of clinical trials. This is a pre-validation study, investigating optimized algorithms, features, functions and wearing comfort. This will be a clinical evaluation which will be conducted mono centric at Sonova AG Headquarters based in Stäfa (Switzerland).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

16

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 Locations

  • Switzerland
    • Zürich
      • Stäfa, Zürich, Switzerland, 8712
        • Sonova AG

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult hearing impaired persons (minimum age: 18 years) with or without experience with hearing aids
  • Good written and spoken (Swiss) German language skills
  • Healthy outer ear
  • Ability to fill in a questionnaire (p/eCRF) conscientiously
  • willingness to wear custom made Hearing aids
  • Informed Consent as documented by signature
  • Benefit with TFG tool at least on one ear

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 in Stäfa (Switzerland)
  • Limited ability to describe listening impressions/experiences and the use of the hearing aid
  • Inability to produce a reliable hearing test result
  • Limited dexterity (not able to change a 10size Hearing aid battery)
  • no Benefit of the TFG tool on both ears
  • Known psychological problems
  • Central hearing disorders

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Device: Extension of Phonak Virto B-Titanium
The extension of Phonak Virto B-Titanium will be fitted to the participants individual Hearing loss.
Device: Extension of Virto B-Titanium
In ear Hearing aid device individually modeled to ear canal geometry to compensate an individual Hearing loss.
Active Comparator: Device: Phonak Virto B-Titanium
The Phonak Virto B-Titanium will be fitted to the participants individual Hearing loss.
Device: Virto B-Titanium
In ear Hearing aid device individually modeled to ear canal geometry to compensate an individual Hearing loss.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visibility and Wearing Comfort
Time Frame: 3 weeks
The primary objective of this study is to evaluate if Virto B-Titanium hearing aids measured with the Titanium FitGuide (TFG) (extension of Virto B-Titanium) are less visible (deeper) than modeling without TFG (Virto B-Titanium) while maintaining wearing comfort on adult participants (new and existing users) with mild to moderately-severe hearing loss (M and P receiver ).
3 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurement of acoustic Feedback Thresholds
Time Frame: 3 weeks
Secondary objective is to compare the acoustic feedback thresholds of the TFG- and without TFG- modeled devices in regard of an adequate sealing effect of the respective devices. Thereby, feedback thresholds, measured with the Phonak Target fitting software, must be comparable to average feedback threshold values of the respective shell forms (IIC / CIC). Acceptable feedback thresholds must guarantee an insertion gain [in dB SPL] of at least 20 dB in a specific frequency range.
3 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
TFG Fitrate
Time Frame: 3 weeks
Another objective is to investigate whether at least 50% of the screened population will get a deeper fitted device by the use of the TFG tool, proven by modelling software
3 weeks

Collaborators and Investigators

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

Sponsor

Sonova AG

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 (Actual)

May 22, 2018

Primary Completion (Actual)

June 22, 2018

Study Completion (Actual)

June 22, 2018

Study Registration Dates

First Submitted

May 7, 2018

First Submitted That Met QC Criteria

June 12, 2018

First Posted (Actual)

June 13, 2018

Study Record Updates

Last Update Posted (Actual)

September 17, 2018

Last Update Submitted That Met QC Criteria

September 14, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Sonova2018_07

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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