MyPhonak App Junior Pediatric Usability and Benefit Investigation

NCT05055453 | Completed Results FDA Device

• 1 other identifier: SRF-85, Sonova 2020_15
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hearing Loss

Outcome Measures

Primary Outcomes (1)

• 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

  Day 1 of study, repeated on Day 14 of study

Secondary Outcomes (1)

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

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

Study Arms (1)

Experimental Study Group

EXPERIMENTAL

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

Device: MyPhonak Junior App; Device: Phonak Sky hearing aid

Interventions

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.

Experimental Study Group

Phonak Sky hearing aid DEVICE

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

Experimental Study Group

Eligibility Criteria

• Age: 7 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Sonova AG: lead

Study Sites (1)

Universitätsmedizin Mainz, HNO-Klinik

Mainz, Rhineland-Palatinate, 55131, Germany

Location

MeSH Terms

Conditions

Hearing Loss

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Jean Anne Schnittker, Research Audiologist
• Organization: Sonova

jeananne.schnittker@sonova.com

+41 58 928 01 01

Study Officials

• Anne K Läßig, M.D, M.D.

  Johannes Gutenberg University Mainz

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2021
• First Posted: September 24, 2021
• Study Start: October 4, 2021
• Primary Completion: December 8, 2022
• Study Completion: December 8, 2022
• Last Updated: June 25, 2024
• Results First Posted: June 25, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)