MyPhonak App Junior Pediatric Usability and Benefit Investigation

Hearing Loss Clinical Trial

Official title:

ESolutions Functions for Children and Young People With the myPhonak App

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05055453
• Other study ID #: SRF-85, Sonova 2020_15
• Status: Completed
• Phase: N/A
• Start date: October 4, 2021
• Est. completion date: December 5, 2022

Study information

• Verified date: April 2022
• Source: Sonova AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: December 5, 2022
• Est. primary completion date: December 5, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 7 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hearing Loss

Intervention

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).

Locations

Country	Name	City	State
Germany	Universitätsmedizin Mainz, HNO-Klinik	Mainz	Rheinland-Pfalz

Sponsors (1)

Lead Sponsor	Collaborator
Sonova AG

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	4 weeks for each subject (2 face-to-face visits + 2 weeks home trial), 12 months in total for study to be completed