- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07526428
Investigating the DNN Noise Reduction Feature in Phonak Hearing Aids Using Ecological Momentary Assessment
The goal of this interventional study is to evaluate the DNN Noise reduction feature of Phonak hearing aids in adults with moderate to moderate severe hearing loss. The main questions it aims to answer are:
Do participants correctly identify significantly more words on the AZBio Sentence Test when using Phonak's DNN NR feature than when using Competitor device A in a lab setting? Do participants subjectively rate the speech clarity, ease of listening, and listening confidence higher when using Phonak's DNN feature than when using Competitor device A in both a lab setting and a real-world cafe setting? Do participants have an overall preference for the Phonak device over the Competitor device A in a real-world cafe setting?
Participants will be fit with both the Phonak device and a Competitor device A in the lab. They will be given the AZBio Sentence test and repeat as many words as they can in a simulated noisy environment. Following the lab visit, participants will meet in a group with three other conversation partners in a real-world setting and asked to complete subjective questionnaires during the visit.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Illinois
-
Aurora, Illinois, United States, 60504-7940
- Phonak Audiology Research Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adults (18+ years old) with audiograms within fitting range of the hearing aid (e.g., moderate to severe sensorineural hearing losses {N3-N5}) and with hearing aid experience will be recruit-ed for this study.
- Ability to fill out questionnaires
- No known cognitive issues.
- Fluent in English, ability to read and write in English.
- Informed consent documented by signature.
- Willingness to wear binaural receiver-in-canal (RIC) devices with domes.
- Willingness to meet up outside of the lab at a local café with two other consented research participants.
Exclusion Criteria:
- Contraindications to medical device (MD) in this study: known hypersensitivity or allergy to investigational product/domes.
- Limited mobility/not being able to come to scheduled appoint-ments.
- Limited ability to describe listening impressions/experiences and the use of the hearing aid.
- Known psychological disorders.
Study Plan
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: Participants fit and tested with the Phonak device first, then the Competitor device A.
Participants that are tested first with the Phonak device, and then with the Competitor device A.
|
Phonak Audeo Infinio RIC
Competitor Device A
|
|
Experimental: Participants fit and tested with Competitor device A first, then with Phonak device.
Participants that are tested first with the Competitor device A, then with the Phonak device.
|
Phonak Audeo Infinio RIC
Competitor Device A
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
AZBio Sentence Test
Time Frame: Day 1 of study
|
A validated speech perception test consisting of 25 different lists of sentences.
Sentences are presented via a loudspeaker at a pre-determined level and the number of words correctly repeated are calculated into a percenteage.
The higher the percentage, the better the participant's speech perception.
|
Day 1 of study
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Composite Questionnaire
Time Frame: Days 1 and 2 of study
|
A 5-point Likert scale questionnaire that asks participants to rate the speech clarity, ease of listening, and listening confidence for each hearing aid.
The scale is from 1 = Strongly disagree, to 5 = Strongly agree.
Participants will be given this questionnaire following the AZBio Sentence test in the lab, and following the group conversation in the cafe.
|
Days 1 and 2 of study
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SRF-36296
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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