MyPhonak App Junior Pediatric Usability and Benefit Investigation

Sponsor
Sonova AG (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05055453
Collaborator
(none)
24
1
1
13
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Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: MyPhonak Junior App
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
24 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
ESolutions Functions for Children and Young People With the myPhonak App
Anticipated Study Start Date :
Oct 1, 2021
Anticipated Primary Completion Date :
Oct 1, 2022
Anticipated Study Completion Date :
Nov 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Experimental Study Group

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.

Device: MyPhonak Junior App
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).

Outcome Measures

Primary Outcome Measures

  1. Change in OLSA score after subjects adjust hearing aid with MyPhonak Junior App [4 weeks for each subject (2 face-to-face visits + 2 weeks home trial), 12 months in total for study to be completed]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
7 Years to 17 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Universitätsmedizin Mainz, HNO-Klinik Mainz Rheinland-Pfalz Germany 55131

Sponsors and Collaborators

  • Sonova AG

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Sonova AG
ClinicalTrials.gov Identifier:
NCT05055453
Other Study ID Numbers:
  • Sonova 2020_15
First Posted:
Sep 24, 2021
Last Update Posted:
Sep 24, 2021
Last Verified:
Mar 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 24, 2021