Back to resultsMyPhonak App Junior Pediatric Usability and Benefit Investigation
Primary Purpose
Hearing Loss
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
MyPhonak Junior App
Sponsored by
About this trial
This is an interventional other trial for Hearing Loss
Eligibility Criteria
Inclusion Criteria:
- Children and adolescents between the ages of 7 and 17 years old.
- With normal middle ear characteristics
- With a hearing impairment in the mild to severe range
- With adequate speech development
Exclusion Criteria:
- Unreliability and lack of cooperation exists,
- An effusion in the middle ear or local inflammation in the ear canal or middle ear with/without a running ear,
- Mental limitations,
- If the patient is unable to operate a smartphone,
- Other objections to study participation in the opinion of the study director exist.
Sites / Locations
- Universitätsmedizin Mainz, HNO-Klinik
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Experimental Study Group
Arm Description
It is a prospective study to investigate whether the MyPhonak Junior app can improve speech understanding in children with hearing aids, by evaluating the use of the volume, noise reduction and directional microphone using the MyPhonak Junior App.. The study is linked to randomized patient and test allocation carried out. Introduction to the MyPhonak Junior app. There are measurements of speech understanding of sentences Carried out in background noise with the Oldenburg sentence test (OLSA). The language test is hard of hearing children and adolescents known from routine clinical practice. Various everyday situations / noise scenarios are played out. Questionnaire (E-HAK, also known from routine) and interview of the children regarding the use of the app in everyday life.
Outcomes
Primary Outcome Measures
Change in OLSA score after subjects adjust hearing aid with MyPhonak Junior App
At the first face-to-face the subject will be trained on the app, and complete the OLSA. After 2 week home trial, the OLSA will be re-administered to see if the adjustments the subjects made using the MyPhonak Junior app impacted speech intelligibility, which would be shown by the OLSA score at the second face-to-face visit.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05055453
Brief Title
MyPhonak App Junior Pediatric Usability and Benefit Investigation
Official Title
ESolutions Functions for Children and Young People With the myPhonak App
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
October 4, 2021 (Actual)
Primary Completion Date
December 5, 2022 (Actual)
Study Completion Date
December 5, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sonova AG
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
ESolutions functions for children and young people with the myPhonak app is a prospective study to investigate whether the myPhonak app can improve speech understanding in children with hearing aids. The study is linked to randomized patient and test allocation carried out.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental Study Group
Arm Type
Experimental
Arm Description
It is a prospective study to investigate whether the MyPhonak Junior app can improve speech understanding in children with hearing aids, by evaluating the use of the volume, noise reduction and directional microphone using the MyPhonak Junior App.. The study is linked to randomized patient and test allocation carried out.
Introduction to the MyPhonak Junior app. There are measurements of speech understanding of sentences Carried out in background noise with the Oldenburg sentence test (OLSA). The language test is hard of hearing children and adolescents known from routine clinical practice. Various everyday situations / noise scenarios are played out. Questionnaire (E-HAK, also known from routine) and interview of the children regarding the use of the app in everyday life.
Intervention Type
Device
Intervention Name(s)
MyPhonak Junior App
Intervention Description
The primary objective is to evaluate the effects on speech intelligibility of resulting from the changes that children and adolescents (aged 7 to 17 years) make to the volume control, directionality and noise reduction of the hearing of the hearing aids using the myPhonak app. First, in a controlled laboratory environment under the guidance of the principal investigator is tested. Then, using sound scenarios, the child is allowed to try out two programs with the aid of using the app and the volume control, respectively. After this, the speech comprehension of sentences in noise is tested in the individual programs using the Oldenburg Sentence Test (OLSA).
Primary Outcome Measure Information:
Title
Change in OLSA score after subjects adjust hearing aid with MyPhonak Junior App
Description
At the first face-to-face the subject will be trained on the app, and complete the OLSA. After 2 week home trial, the OLSA will be re-administered to see if the adjustments the subjects made using the MyPhonak Junior app impacted speech intelligibility, which would be shown by the OLSA score at the second face-to-face visit.
Time Frame
4 weeks for each subject (2 face-to-face visits + 2 weeks home trial), 12 months in total for study to be completed
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Children and adolescents between the ages of 7 and 17 years old.
With normal middle ear characteristics
With a hearing impairment in the mild to severe range
With adequate speech development
Exclusion Criteria:
Unreliability and lack of cooperation exists,
An effusion in the middle ear or local inflammation in the ear canal or middle ear with/without a running ear,
Mental limitations,
If the patient is unable to operate a smartphone,
Other objections to study participation in the opinion of the study director exist.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne K Läßig, M.D, M.D.
Organizational Affiliation
Johannes Gutenberg University Mainz
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universitätsmedizin Mainz, HNO-Klinik
City
Mainz
State/Province
Rheinland-Pfalz
ZIP/Postal Code
55131
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
MyPhonak App Junior Pediatric Usability and Benefit Investigation
We'll reach out to this number within 24 hrs