MyPhonak App Junior Pediatric Usability and Benefit Investigation

Sonova AG16 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Hearing Loss

Interventions

MyPhonak Junior AppDEVICE

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 aidDEVICE

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

Eligibility

Sex: ALLMin age: 7 YearsMax age: 17 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Universitätsmedizin Mainz, HNO-Klinik

Mainz, Rhineland-Palatinate, Germany

Outcomes

Primary Outcomes

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

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

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

Secondary Outcomes

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

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.

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

Data from ClinicalTrials.gov

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