ESolutions Functions for Children and Young People With the myPhonak App
Phase: NA
Conditions: Hearing Loss
Sponsor: Sonova AG

 
Study Protocol and Statistical Analysis Plan 
 
 
 
 
 
eSolutions Functions for Children and Young People 
 
 
 
 
Version 2 
 (translated to English from original version) 
 
December 1 2023 
 
Version 1 was completed July 1, 2020 in German 
 
 
 
NCT05055453 
 
 
 
 

Protocol Title 
 
eSolutions functions for children and young people 
 
1 
Background    
 
The main goal of providing early hearing aids in childhood is to ensure that the child's language 
development is as normal as possible. However, children's hearing needs change as they grow 
older. A growing child is exposed to many new listening environments, which often include 
multiple sound sources and loud everyday noises. In such situations it can sometimes be very 
difficult for the child to understand speech clearly. The older a child gets, the more often 
communication usually takes place in acoustically complex environments in which the audibility 
of the speech signal can be significantly impaired. Numerous studies show that poor 
acoustic conditions impair the speech intelligibility of children with normal hearing more than 
that of adults with normal hearing (McCreery et al., 2010; Wroblewski al., 2012; Yang & Bradley, 
2009). In addition, poor acoustic conditions have a negative impact on children's ability to learn 
and thus their academic success (Dockrell & Shield, 2004; Klatte, Hellbrück, et al., 2010). 
 
Speech recognition and speech understanding in noisy environments is a challenge for people 
who are hard of hearing, but it is particularly difficult for children and young people. Especially in 
learning situations, directional microphones and noise cancellation functions in hearing aids can 
lead to improved speech recognition when speech and noise come from different directions. 
 
However, these technologies offer only limited benefits and in certain cases the use of, for 
example, a directional microphone hearing aid mode can also have a detrimental effect. In 
recent years, initial studies have been carried out on the usability of directional microphone 
systems and noise suppression functions in pediatric care. However, so far there is little 
evidence about directional microphone use, spatial hearing and the possible benefits of 
directional microphones in children's everyday environments. The few studies that have been 
carried out so far also show contradictory results. While one study shows (Ching et al., 2009) 
that directional microphones are more effective than omnidirectional microphones in speech 
recognition when speech comes from the front and background noise occurs directly behind the 
listener, another study shows that omnidirectional microphones are more effective, when 
language comes from different directions, which is quite often the case with younger children, as 
they often have a different “head position” when listening 
than adults. In one study, half of the children preferred directional microphones in most 
situations, whereas the other half preferred omnidirectional microphones (Ricketts et al., 2007). 
In another study, both children and parents rated both types of microphones equally well 
(McCreery et al. 2010). 
 
Nowadays almost all modern hearing aids have automatic systems (e.g AutoSense), which are 
able to independently control the change between omnidirectional microphones and directional 
microphones. Overall, it appears that directional microphones can be useful in some of the 
many different acoustic environments that children and young people are exposed to, either at 
home, at school or in social situations. However, there are also situations in which directional 
microphones may not be advantageous or may even be disadvantageous (Wolfe et al., 2017). 
This applies both to adaptive systems in which the hearing aid makes the selection itself 
(AutoSense) and to systems in which the child is supposed to make the decision himself. 
 
It is believed that directional microphones and noise cancellation functions could also 

be beneficial for children and young people in general if there is more detailed knowledge 
about the extent and in which environments children need these functions. This study 
is intended to help understand when, to what extent and at what age these functions are 
beneficial for children and young people in order to be able to adapt the design of these 
functions and thus the programming of hearing aids more individually to children and 
young people. 
 
2 
Objectives 
 
The primary objective is to evaluate the impact on speech intelligibility resulting from 
the changes that children and adolescents (aged 7 to 17 years) make to the microphone 
directionality and noise cancellation of their hearing aids using the myPhonak 
app. 
 
 
3 
Description of the investigational device 
 
The devices used in this study are CE certified and commercially available:  Phonak Sky M90-M 
or Sky M90-SP hearing aids and the myPhonak app. These are manufactured and maintained 
by Sonova, AG located in Stafa, Switzerland. 
The overall intended purpose of the hearing aid device is to amplify and transmit sound to the 
ear and thereby compensate for impaired hearing. The myPhonak app is an accessory to a 
medical device (hearing aid with wireless functionality). It is used as a remote control to a 
hearing aid. The app is a software application which is installed and used on a smartphone with 
an Apple iOS or with an Android OS. The myPhonak app allows the end-user to adjust certain 
parameters of Phonak hearing aids, such as volume, program changes, microphone 
directionality, and noise reduction and is intended for use with compatible Android or Apple iOS 
devices. The app itself is classified as a medical device (class II) but is not needed to enable the 
hearing aids to be used according to their intended purpose. 
 
4 
Design of the clinical investigation 
 
This investigation is a single-group, single site, interventional study.  
 
5 
Risks and benefits of the investigational device and clinical investigation 
 
There are minimal risks associated with both the investigational device and participating in the 
clinical investigation. Identified risks are no greater than those associated with the daily use and 
wear of approved, available hearing aids. The device used presents non-significant risk per FDA.  
The benefits of participating in the investigation include the possibility of hearing sounds that 
have not been previously heard, such as speech and environmental sounds, which may 
improve communication in daily life. Subjects may experience the benefit of personal 
satisfaction for participating in research to improve hearing instrument technology. Subjects will 
also be compensated for their time in participating in this study. 
There are no known or anticipated risks to subject hearing ability associated with participation in 
this study. All sounds used in this study will be presented at safe listening levels. While using 
hearing aids, the following are possible occurrences: 
 
•Cerumen impaction 
 
•Ear discomfort, pain or soreness 
 
•Sweat or moisture accumulation in the ear canal or pinna 

 
•A feeling of pressure or fullness in the ear 
 
•Itching, blisters, or sores in the ear canal or pinna 
 
•Headache 
 
•Redness of tissue 
The research personnel will review these risks with the subjects and answer any questions they 
have. Hearing aids are not a significant risk investigational device as defined in the FDA 21 CFR 
812.3(m). 
 
6 
Endpoints 
The primary endpoint will be the difference in SRT- 50 levels using the adaptive Oldenburg 
Sentence Test (OLSA) between the following conditions: 
1. Hearing aid Autosense Sky OS  
2. Hearing aid Preferred setting (manual adjustments to the Noise Reduction and 
Directionality) 
3. Hearing aid extreme setting with the Noise Reduction set to maximum and the 
Directionality set to minimum. 
 
7 
Inclusion and Exclusion Criteria 
The participants will be recruited from the clinic’s patient population. 
 
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 
 
8 
Measurements and procedures 
 
The investigation will have two lab visits and one home trial. The procedures are as follows: 
 
Visit 1 
Home Trial ~ 2 weeks 
Visit 2 
Audiogram, if needed 
Obtain informed consent from 
parents  
Fit study devices to match 
that 
of 
personal 
devices, 
verified 
with 
coupler 
measurements 
Download myPhonak Jr app 
to 
personal 
or 
loaner 
smartphone and pair with 
Participant instructed to use 
the 
app 
in 
five 
different 
situations and rate the ease 
of each situation, using the 
Assessment 
of 
hearing 
situations in children’s every 
day lives”.- To be completed 
after one week, and then after 
the second week. 
Repeat dB SNR testing 
using OLSA (randomized 
order) : 
1. AutoSense Sky OS 
2. Preferred Setting  
3. Extreme setting 
Interview and discussion of 
questionnaire results 

study hearing aids 
Train on app use 
dB SNR obtained using the 
OLSA test with study devices 
in the following conditions: 
(randomized order): 
1. AutoSense Sky OS 
2. Preferred Setting  
Extreme setting Give 2 copies 
of  “Assessment of hearing 
situations in children’s every 
day lives” to complete during 
home trial 
 
The test environment is set up as follows: 
Cafeteria noise at 65 dBA, from four speakers (-50°, +50°, -130°, +130°) 
Speech presented at 70 dBA, from front speaker (0°) 
 
9 
Statistical design and analysis 
 
The variance known from the OLSA manual between normal hearing subjects aged 7-9 years is 
3 dB, and 1.5 dB for adults over the age of 18. 
A significance level of 0.05, a power of 0.8 and the approximate variance of 3 dB, a sample size 
of 24 is needed. 
 
A non-paremetric RM-ANOVA will be used for comparing the group OLSA results for the 
different conditions. Durbin-Conover pairwise comparisons will be used for post hoc analysis. 
 
 
 
10 
Investigation Duration 
 
The study is expected to last approximately 12 months to account for recruitment. 
Each participant’s expected study duration is approximately 4-6 weeks. 
Each clinic appointment is expected to last between 1-2 hours. 
 
11 
Data handling and management 
 
Paper based CRFs will be used to capture the participant data. Both the objective data and the 
subjective data from the questionnaires will be manually transferred by the investigator to an 
electronic system, such as Microsoft Excel.  

All CRFs are kept current to reflect the subject’s status at each phase during the course of study. 
Participants cannot be identified in the CRF by name or initials and birth date but an appropriate 
coded identification is used. All study team members are authorized for the CRF entries and it is 
assured that any authorized person can be identified both for pCRFs and eCRFs. If pCRFs are 
used, the investigator’s initials and subject ID are documented and data are entered into an 
electronic file for analysis by the respective investigator and data will be monitored by the 
assigned monitor. In case of a self-evident correction, either the subject does it by himself or the 
investigator undertakes the correction by crossing out the word/sentence with a single horizontal 
line and by adding the correction including his personal identifier and the date. 
The pCRFs are only available to the local study team and to the monitor of the study. 
In the case of an audit or a serious adverse event, the CRFs may need to be de-anonymized 
and sent to the governing or notified body. 
All paper-based data will be stored in a locked filing cabinet at the investigation site. All 
electronic data will be stored on an access-restricted computer owned by the investigation site. 
Permission to access data will be limited to study manager, monitor, PI, and essential research 
staff, as designated by the principal investigator.  
During data collection of the investigation, physical copies of the data may be compiled and 
digitized by the investigator. 
Data will be reviewed for mis-entries or inaccuracies as each data set is entered.  
The extent and nature of monitoring appropriate for the clinical investigation including the 
strategy for source data verification (SDV) are based on considerations such as the objective, 
design, complexity, size critical data points and endpoints of the clinical investigation. A de-
tailed plan for monitoring arrangements is provided separately from this CIP. 
 
12 
Amendments to the CIP 
 
Any necessary amendments to the CIP will be communicated to the study manager/sponsor. 
A new version of the CIP will be written, with the necessary changes and justification. The 
amended CIP will go through the necessary approval process. 
 
13 
Deviations from clinical investigation plan 
 
Deviations from the CIP to protect the rights, safety and well-being of human participants under 
emergency circumstances may proceed without prior approval of the sponsor and the EC – 
such deviations will be documented and reported to the sponsor representative (Study Manager) 
and the EC as soon as possible. Apart from that the investigator is not allowed to deviate from 
this CIP unless that deviation does not influence the investigation data.  
 
14 
Device accountability 
 
Sonova, in its capacity as sponsor, will maintain a log of all investigational devices, including the 
date of shipment from Sonova to the site, serial number, receiving study site, and date returned 
to Sonova. 
The site will maintain a log of the devices provided by Sonova, including the date of 
receipt,serial number, date of fitting, participant identification, date of return to site by participant, 
and date returned to Sonova. Sonova will provide each site a template with which to record 
such information. 

If a device needs to be replaced due to a device deficiency, the PI or sub-investigator will add 
the new device serial number, date of receipt, and date of return of the defective device on the 
Device Accountability Log. 
In the case of a device deficiency, the Adverse Event-Device Deficiency form will be completed 
by the study manager and the PI or sub-investigators together. 
 
15 
Informed consent process 
 
Informed consent will be obtained from the legal guardians of the participants prior to any study 
participation in accord-ance with the ethics guidelines. The legal guardians will be granted 
sufficient time to read through the consent in full and ask any questions they have before 
signing. After the legal guardian signs the consent form, the researcher will sign and provide a 
copy to the legal guardian.  
 
16 
Adverse events, adverse device effects and device deficiencies 
 
Device deficiencies and all adverse events (AE) including all serious adverse events (SAE) 
are collected, fully investigated and documented in the source document and appropriate case 
report form (CRF) during the entire investigation period, i.e. from participant’s informed consent 
until the last protocol-specific procedure, including a safety follow-up period (ISO-14155, 2020). 
Documentation includes dates of event, treatment, resolution, assessment of serious-ness and 
causal relationship to device and/or investigation procedure.  
Information on AEs is systematically collected during the regular investigation visits, and phone 
calls (if applicable).  
  
The reporting of Serious Adverse Events and Device Deficiencies follows the Regulation (EU) 
2017/745 and the MDCG 2020-10/1 Safety Reporting in Clinical Investigations of Medical 
Devices under Regulation (EU) 2017/745. 
The causality assessment of the SAE will be conducted according to MDCG 2020-10/1 Safety 
Reporting in Clinical Investigations of Medical Devices under Regulation (EU) 2017/745. 
 
 
 
17 
Vulnerable populations 
 
This investigation includes children age 7 to 17. 
 
18  
Suspension or premature termination of the clinical investigation 
 
The study will be terminated if the majority of the participants are not able to wear the devices 
for the study visit.  
The study will be terminated if the participants or researchers are exposed to safety risks other 
than those outlined in this document.  
The study may be terminated in the event natural disasters, widespread outbreak of illness, 
compromised structure of the investigation site, etc. that would make continuation of the study 
impossible or impractical. The study will be suspended within 5 days of determination that the 
study or device put participants at an unreasonable risk.  
If a participant is suspended, terminated, or withdraws from the study, their data can be traced 
with their unique study identification number.  

Follow up of any SAEs will be conducted by the study manager and/or the PI until the nature of 
the event is resolved. 
 
19 
Publication policy 
 
The clinical investigation will be registered in clinicaltrials.gov, a publicly accessible database, 
as required by U.S. regulations.  
An internal report of the results of this investigation will be completed and uploaded to eQMS. 
The PI may publish results at the completion of the investigation.