Quality Control of CE-Certified Phonak Hearing Aids - Sonova2018_05
1 other identifier
interventional
15
1 country
1
Brief Summary
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 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2018
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 12, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 13, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2018
CompletedFirst Submitted
Initial submission to the registry
September 14, 2018
CompletedFirst Posted
Study publicly available on registry
November 23, 2018
CompletedNovember 23, 2018
November 1, 2018
1 month
September 14, 2018
November 21, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Comparison of the speech intelligibiltity of phone calls via direct streaming
The primary outcome meaurement of this study is the comparison of Phonak's direct connectivity solution against two competitors in terms of subjective speech intelligibility of streamed audio signals via smartphone. The subjective speech intelligibilty will be measured via interview (sound quality rating, satisfaction rating of speech intelligibility) from far-end talker and near-end talker.
6 weeks
Secondary Outcomes (1)
Investigation of Bluetooth Connection losses between Hearing Aid and smart phone during a phone call (number of reported interruptions during a phone call which will be streamed via bluetooth from Smartphone to Hearing Aid)
6 weeks
Other Outcomes (2)
Comparison of the subjective Sound Quality rating of TV-Audiostream via direct connectivity
6 weeks
Comparison of the Usability of remote controls via direct connectivity
6 weeks
Study Arms (3)
Phonak Audéo B90-Direct
EXPERIMENTALThe Phonak Audéo B90-Direct is the most recent Receiver-in-the-canal Hearing aid with direct connectivity functionality from Phonak which will be fitted to the participants individual Hearing loss.
HearingAid_A
ACTIVE COMPARATORHearingAid\_A is the most recent Receiver-in-the-canal Hearing aid with direct connectivity functionality from manufacturer\_A which will be fitted to the participants individual Hearing loss.
HearingAid_B
ACTIVE COMPARATORHearingAid\_B is the most recent Receiver-in-the-canal Hearing aid with direct connectivity functionality from manufacturer\_B which will be fitted to the participants individual Hearing loss.
Interventions
The Phonak Audéo B90-Direct is the most recent Receiver-in-the-canal Hearing aid from Phonak which will be fitted to the participants individual Hearing loss.
HearingAid\_A is the most recent Receiver-in-the-canal Hearing aid from manufacturer\_A which will be fitted to the participants individual Hearing loss.
HearingAid\_B is the most recent Receiver-in-the-canal Hearing aid from manufacturer\_B which will be fitted to the participants individual Hearing loss.
Eligibility Criteria
You may qualify if:
- Adult hearing impaired persons (minimum age: 18 years, mild to moderate Hearing loss) without hearing aid experience
- Good written and spoken (Swiss) German language skills
- Healthy outer ear
- Ability to fill in a questionnaire (p/eCRF) conscientiously
- willingness to wear Receiver in the canal hearing aids
- Informed Consent as documented by signature
- owning an iPhone 6 or higher
You may not qualify if:
- 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
- Known psychological problems
- Central hearing disorders
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sonova AGlead
Study Sites (1)
Sonova AG
Stäfa, Canton of Zurich, 8712, Switzerland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- Participant masking was only done for laboratory measurements. For home trial testing no masking was done.
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 14, 2018
First Posted
November 23, 2018
Study Start
March 12, 2018
Primary Completion
April 13, 2018
Study Completion
May 31, 2018
Last Updated
November 23, 2018
Record last verified: 2018-11