Performance of a Hearing Aid Platform Including Different Styles of Hearing Aids
Structured Post Market Clinical Follow-up (PMCF) to Evaluate the Quality of a New Hearing Aid Product Generation.
1 other identifier
interventional
253
1 country
1
Brief Summary
The reason for this study is to evaluate a new hearing aid product generation replacing the one on the market. The goal is to evaluate the audiological performance, usability as well as features and functions.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2013
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2013
CompletedFirst Submitted
Initial submission to the registry
November 17, 2014
CompletedFirst Posted
Study publicly available on registry
November 24, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2015
CompletedMay 3, 2016
May 1, 2016
2.3 years
November 17, 2014
May 2, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Difference of speech intelligibility between devices based on Quest platform and Venture platform for different hearing aid styles
For the objective measurements in laboratory situation, both a standard German speech sentence test in noise (SRT in dB) and a standard German monosyllable word test in quiet (speech discrimination in percent) are used to compare the speech intelligibility for both platforms. The results of the Venture platform of both tests should be at least the same or better than with the Quest platform.
3 years
Secondary Outcomes (3)
Subjective ratings of speech intelligibility during home trials
3 years
Subjective ratings of sound quality during home trials
3 years
Subjective ratings of usability during home trials
3 years
Study Arms (1)
Hearing aid
OTHER172 subjects with a mild hearing loss. 140 subjects with a moderate hearing loss. 70 subjects with a severe/ profound hearing loss.
Interventions
The hearing aid will be fitted to the individual hearing loss of the subject.
Eligibility Criteria
You may qualify if:
- all kinds of hearing loss (sensorineural, conductive, combined)
- all kinds of hearing loss (flat, sloping) which are in the fitting range of the hearing aids
- mother tongue (swiss) german
You may not qualify if:
- Subjects
- with a reduced mobility unable to attend weekly study appointments
- without access to a number of different hearing situations
- with strongly reduced ability to describe auditory impressions and the usage of the hearing aids
- which are uncooperative so that it is not possible to record a valid pure tone audiogram
- with a strongly reduced dexterity
- with psychological problems
- central hearing disorders
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Phonak AG
Stäfa, Canton of Zurich, 8712, Switzerland
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Simone Ebbing, B. Sc.
Phonak AG
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 17, 2014
First Posted
November 24, 2014
Study Start
May 1, 2013
Primary Completion
August 1, 2015
Study Completion
September 1, 2015
Last Updated
May 3, 2016
Record last verified: 2016-05