Skip to main content
OpenTrials
Completed

NCT Number: NCT05055453

MyPhonak App Junior Pediatric Usability and Benefit Investigation

Participants age 8-17 with bilateral hearing loss will be fit with Phonak BTE (Behind-The-Ear) hearing aids and given access to the myPhonak Junior hearing app. The participants will use the app to adjust the hearing aid microphone and noise reduction settings.

Completed

Looking for future studies?

Notify Me

Key information

Age range

7 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universitätsmedizin Mainz, HNO-Klinik

Mainz, Rhineland-Palatinate, 55131, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Children and adolescents between the ages of 7 and 17 years old.
  • bilateral mild to severe hearing loss
  • experienced hearing aid users for 6+ months

Exclusion criteria

  • any additional disabilities to the hearing impairment
  • inability to complete the study procedures

Treatment and study plan

MyPhonak Junior App

Device

The app is an accessory to the hearing aids which allows the user to make adjustments to their hearing aid in real-time. The hearing aid does not require the use of the app, but the objective of this study is to evaluate the effects of the user adjustments made via the app on the participant's speech intelligibility with the hearing aid.

Phonak Sky hearing aid

Device

A Behind-The-Ear hearing aid (BTE) fit to hearing impaired persons with mild to severe hearing loss.

Primary outcomes

  1. dB SNR (Decibel Signal to Noise Ratio) Score Using the OLSA (Oldenburg Sentence Test) Speech in Noise Test

    Time frame: Day 1 of study, repeated on Day 14 of study

    Target speech is presented from a speaker in front of participant while background noise is presented from 4 surrounding speakers. The level of noise is presented at 65 dB SPL (Sound Pressure Level),with target speech presented at variable levels, both louder and softer than the noise. The dB SNR is the level at which the participant can correctly repeat 50% of the words. A lower/negative dB SNR is better, indicating that 50% of the speech is understood when noise is louder than or close to the level of speech. This test was given in three, randomized conditions for each participant at two visits: 1) hearing aids in Automatic, 2) hearing aids in Automatic but Directionality and Noise Reduction customized by participant using the app (i.e. "preferred" settings), and 3) hearing aids in Automatic but with the Directionality set to lowest level 0, (i.e. omnidirectional), and Noise Reduction set to the highest level 10,or all the way on (i.e., "extreme").Results of both visits was averaged

Secondary outcomes

  1. Assessment of Hearing Situations in Children's Every Day Lives Questionnaire

    Time frame: Completion of first home trial at day 7, and completion of second home trial at day 14

    A German-language questionnaire which asks student to rate their listening quality in different environments. Participants compared their listening quality with hearing aids alone versus hearing aids plus the app. Rating scale is from 1 to 5 with 1 = mostly easy and 5 = mostly difficult, so a lower score is better, however a rating of 0 = no change. Participants were given one copy of questionnaire to fill out during week 1 of home trial, and a second copy to fill out during week 2 of home trial. Results are reported separately for week 1 and week 2.

Sponsors and collaborators

Lead sponsor

Sonova AG

Industry

Registry information

Official study title

ESolutions Functions for Children and Young People With the myPhonak App

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Sep 24, 2021
Registry last updated
Jun 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.