Hearing Aid Transmitter Performance Study - SRF-366
Phase: NA
Conditions: Hearing Loss
Sponsor: Sonova AG

 
 
 
Study Protocol and Statistical Analysis Plan 
 
 
Active vent Performance Study – ID# 366 
May 11, 2022 
 
NCT04774185 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
Active vent Performance Study – ID SRF-366 
 
1 Objectives and hypotheses of the clinical investigation 
1.1 Purpose of the clinical investigation claims for clinical performance, 
effectiveness or safety of the investigational device that are to be 
verified  
(P) The patient poblem is own-voice amplificaiton with closed vents. (I) A conventaional so-
lution are open dome fittings. However the side effect is reduced low frequency sound pro-
cesing in hearing aids, and thus reduce sound processor benefit. Sonova has introduced an 
active vent feature based on a new RIC with an internal actuattor that controls a physical 
venting mechanism. (C) Thus the investigation will focus on the comparison between hearing 
aids fitted with the new active vent over an open dome. (O) The active vent is expected to 
provide 
 
a. 
Improved speech intelligibility when listening to speech in noise using beam-forming 
in a closed-vent condition,  
a. 
Improved sound quality of streaming music and speech when in a closed-vent 
condition, and  
b. 
Comparable own-voice comfort in an open-dome condition.  
 
1.2 Primary and Secondary Objectives  
Primary Objective:  
Evaluate whether Phonak Audéo P90-R in combination with an ActiveVent (AV) receiver pro-
vides better speech intelligibility for speech in noise than Phonak AudéoP90-R with a 
standard receiver and an appropriate* standard dome AND providing natural sound in 
everyday listen-ing situations for people with mild to moderate hearing loss.  
Secondary Objective(s):  
Evaluate whether Phonak Audéo P90-R in combination with an ActiveVent (AV) receiver im-
proves listening effort compared to Phonak AudéoP90-R with a standard receiver and an ap-
propriate* standard dome in everyday listening (communication) situations for people with 
mild to moderate hearing loss.  
Evaluate whether Phonak Audéo P90-R in combination with an ActiveVent (AV) receiver pro-
vides same own voice perception than Phonak Audéo P90-R with a standard receiver and an 
appropriate* standard dome for people with mild to moderate hearing loss.  
Evaluate whether Phonak Audéo P90-R in combination with an ActiveVent (AV) receiver im-
proves sound quality compared to Phonak AudéoP90-R with a standard receiver and an ap-
propriate* standard dome when listening to streamed music and speech for people with mild 
to moderate hearing loss. 
 

 
 
2 Design of the clinical investigation 
2.1 General  
2.1.1 Design Type  
The study will be a single-blinded randomize cross-over design. The comparison of devices 
will be done within participant, whereby each participant will be asked to perform a 
behavioral assessment using both fitting modalities, active vent and open dome. 
2.1.2 Procedures  
2.1.3 Investigation-related Procedure  
Participants will not be treated for hearing loss. A standard PTA will be administered during 
the appointment for the purpose of candidature screening and fitting the hearing aids for test-
ing. The hearing aids will be fitted to match NAL-NL2 targets, using standard audiometric 
procedures. 
3 Statistical design and analysis 
3.1 Determination of Sample Size 
Power analysis using published data [Keiser et al., International Journal of Audiology Volume 
52, 2013 - Issue 11] suggest that to reached sensitive of 1 dB shift in intelligibility thresholds 
between RIC closed to open states, the study requires N = 21 (Z-statistics), at at δ = 1.41 dB, 
α = 0.05, β= 0.1. 
Due to the low sensitivity of the intelligibility test we planned to include 26 participants 
3.2 Statistical criteria of termination of trial 
Describe the criteria for the termination of the trial or the stopping rules. Trial will be 
terminated if the participant is not able to 
1. If this not possible to reach convergence in the adaptive intelligibility test, which 
requires a standard error of 0.8 dB SNR. 
3.3 Planned Analyses 
The statistical analysis plan includes the methods and types of the analysis, the variables the 
data sets and the timeframe when the (interim) analysis is planned. 
3.3.1 Datasets to be analyzed, analysis population 
n/a 
3.3.2 Primary Analysis 
A linear mixed effect model will be used to analyze the intelligibility and sound quality 
benefits. The fixed effects in this model will be fitting modalities (AV: closed, AV vent open, 
Open dome), average hearing loss (in dB HL), and order of feature tested (first or second). 
The random effect will be a subject-specific intercepts. This analysis will be conducted by the 
PI. 
3.3.3 Secondary Analysis 
ANOVA for own voice investigation. 
This analysis will be conducted by the PI. 
Amendment will be done if the protocol of the home trial is developed. 

 
 
3.3.4 Interim Analysis 
Analysis is done on regular basis for updating the sponsor on the available data set. 
=> no final conclusions! 
3.3.5 Safety Analysis 
Describe the analysis of the safety parameters that will be done, when and how and by 
whom it will be done. 
In case of reported AEs those will be reported to the ethic committee and the study manager 
within 24h. 
3.3.6 Deviation(s) from the original statistical plan  
Any additions or changes of the statistical analysis will be reported in the study report with 
proper justification.  
3.3.7 Handling of missing data and drop-outs  
In case of missing data those will be ignored but the remaining data set will be considered in 
data analysis especially because of the small sample size. 
4 Informed consent process 
4.1 Process for obtaining informed consent  
NAL processing requires participants to be identified from the NAL database or from the 
Hearing Australia database. All participants listed in the NAL database are volunteers willing 
to participate in re-search. All participants from hearing Australia are clients of Hearing 
Australia who have not opted out of research with NAL during their registration to received 
clinical services.  
Regardless of the database source, participants are first contacted by phone, mail or email, 
depending on their preferred contact methods. An invitation letter is sent to them which 
describes the task involved and the overall aim of the study. The invitation letter template is 
attached to the ethics documentation. Their participation is voluntary, but they are told of the 
payment they will be received upon participation. The payment is calculated based on the 
effort of the task required by the study, distance of travel requirements to attend the clinic, 
and urgency of recruitment, e.g., high pay is provided for longer lengths of travel and longer 
appointments.  
Upon responding to mail or email invite letter, participants are contacted, with the preferred 
method being a phone call unless participants prefer an alternative approach. During this 
call, participants are given a more detailed description of the task required by the study, 
appointments times available, and payment methods. At this point, if participants wish to 
proceed, a time is scheduled to start the appoint-ment.  
Upon participant arrival, the first task is to sign off the consent form, as per the ethics 
application. Before signing the consent form, participants are asked if they have any 
questions or concerns about the study. 
Information is provided as best understood by the clinician at the time. 
Suppose that at any time during the appointment the task divergences from protocol and this 
impacts on timing or data collected. In that case, an explanation is provided to the participant 
if they are willing to remain for an extra period or stop at the agreed time, with no penalty to 
payment. Depending on the extension of the additional work, additional payment may be 
offered.