Clinical Trial of Roger Adaptive Digital Technology
Phase: NA
Conditions: Hearing Loss, Sensorineural
Sponsor: Northwestern University

Clinical Trial of Roger Adaptive Digital 
Technology 
Remote Microphone Candidacy Study 
NCT03897634 
Final IRB Revision: 2.14.2020 
ClinicalTrials.gov upload 2.24.2021 

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PROTOCOL TITLE:
Remote Microphone Candidacy Study
PRINCIPAL INVESTIGATOR:
Pamela Souza
Communication Sciences and Disorders
Number: 847-491-2433
p-souza@northwestern.edu
CO-INVESTIGATOR:
N/A
STUDENT INVESTIGATOR:
N/A
VERSION DATE:
2/14/2020
IRB #: STU00209649 Approved by NU IRB for use on or after 2/14/2020 through 2/13/2021.

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1.0
Study Summary
Investigational Agent(s) 
(Drugs or Devices)
Roger Select (Remote microphone manufactured by 
Phonak, subsidiary of Sonova)
IND / IDE / HDE # IDE Exempt: This is a legally marketed device and will 
be used in accordance with its labeling. 
Indicate
Special Population(s)
Children 
 Children who are wards of the state 
 Adults Unable to Consent  
 Cognitively Impaired Adults 
 Neonates of Uncertain Viability 
 Pregnant Women 
 Prisoners (or other detained/paroled individuals) 
 Students/Employees 
Sample Size
40
Funding Source
Sonova
Indicate the type of consent 
to be obtained
Written 
Verbal/Waiver of Documentation of Informed Consent
Waiver of HIPAA Authorization 
Waiver/Alteration of Consent Process  
Site
 Lead Site (For A Multiple Site Research Study)
 Data Coordinating Center (DCC)
Research Related 
Radiation Exposure
Yes 
 No 
DSMB / DMC / IDMC
Yes 
No
2.0
Objectives:
Despite improvements in digital hearing aid technology, many individuals with hearing 
loss continue to report difficulty understanding speech in challenging listening 
environments. Remote microphones have been shown to provide benefit in many of the 
most common challenging listening environments: distant speakers, background noise 
and reverberation. Despite demonstrated benefit, there is a low rate of remote microphone 
use amongst adults with hearing–impairment. One reason for low uptake may be an 
uncertainty amongst hearing healthcare providers and potential users regarding expected 
clinically relevant benefit. This clinical trial, funded by Sonova, will attempt the 
following: 
1.  To describe the range of Roger remote microphone benefit among adults with mild-to-
moderate sensorineural hearing loss
2.  To determine specific individual factors beyond the audiogram that are associated 
with greater Roger remote microphone benefit.
3.0
Background / Literature Review / Rationale for the study:
Even when wearing well-fit hearing aids, many individuals with hearing loss continue to 
report difficulty communicating in background noise is one of the most common 
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complaints of individuals with hearing loss.  Directional microphones can improve 
speech perception in noise, but often fail to provide benefit in cases where the talker is 
distant from the listener, where there are multiple or moving noise sources, or in 
reverberation.  Digital noise reduction may reduce listening effort and improve listening 
comfort but has minimal effect on speech perception.  
Placing the microphone in close proximity to the talker reduces the effective distance 
between speaker and listener, compensating for the effects of background noise and 
reverberation on the target signal. Use of a remote microphone can significantly improve 
signal-to-noise ratio (SNR), thereby improving speech perception in noise and at a 
distance.  Recent studies demonstrated that remote-microphone devices that utilize 
adaptive digital technology (i.e., Roger) provide significantly more benefit for speech 
understanding in noise than non-adaptive remote microphones. Those advantages are 
likely related to the adaptive nature of the device, whereby the microphone gain varies 
according to the level of noise in the environment.  In addition, interference is reduced 
via transmission of short digital bursts (160 μs) across a range of channels (2.4-2.4835 
GHz). Further, the ability to utilize the hearing aids’ onboard directional microphones in 
conjunction with a remote microphone gives listeners the benefits of remote microphone 
use without sacrificing nearfield intelligibility. The Roger system has also been shown to 
improve cell phone communication amongst cochlear implant patients. 
Despite demonstrated advantages, use of remote microphone assistive devices among 
adults is low. In a recent study of listeners with severe hearing loss—a group which has 
substantial difficulty communicating in background noise and is likely to receive 
significant benefits from remote-microphone devices—less than 10% reported use of a 
remote microphone.  While cost may be a barrier for some users, even when such 
systems are available for free (as in the Veterans Administration), use is still low.  One 
reason may be uncertainty among both providers and potential users as to expected 
benefit for a given listener. For example, Wolfe et al. 2015 found significant 
improvements in objective speech recognition on average, but with a wide range of 
benefit (from 10% to 60% improvement across individual participants). That study also 
suggested that individual factors may affect remote microphone benefit, in that the 
magnitude of improved recognition was correlated with the ability to use spatial cues to 
improve recognition.  
4.0
Study Endpoints
Primary Endpoint: Benefit from use of a remote microphone.
1. Abbreviated Profile of Hearing Aid Benefit (APHAB): This is a measure of 
hearing aid benefit that is standard in clinical practice. Participants will complete 
this questionnaire to compare perceived aided benefit with hearing aid alone vs 
hearing aid+ remote microphone. 
Secondary Endpoints: In order to build a better profile of patients who may benefit from 
a remote microphone, several measures of hearing ability, manual dexterity, personality, 
and social activity are included. 
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2. Audiometric evaluation including hearing and health history, air and bone 
condition testing, measurement of loudness discomfort level and real-ear 
assessment of current hearing aids.  These are all standard clinical assessments.  
3. MoCA test: The Montreal Cognitive assessment is a cognitive screening test 
designed to detect mild cognitive impairment. It requires approximately 10 
minutes and assesses short-term recall, visuospatial abilities, executive function, 
attention, working memory, language, and orientation to time and place. 
4. Practical Hearing Aid Skills Test-Revised (PHAST-R)- will be used to ensure 
participants are able to use the trial devices
5. Unaided and Aided speech in noise testing: This is a standard clinical measure of 
an individual’s ability to hearing and understand speech in background noise. 
6. Speech, Spatial, and Quality of Hearing Scale (SSQ) pre- and post- Roger use: 
Evaluates an individual’s perceptions of their hearing abilities in a variety of 
every day scenarios. 
7. Acceptable Noise Level (ANL): This test has been shown to be correlated with 
successful hearing aid use.  
8. LiSN-S: Spatial auditory information assessment. This test has been shown to 
correlate with successful assistive listening device use.
9. Level of social activity, using the HRS Activities and Time Use subscale
10. Personality, using the Positive and Negative Affectivity Scale (PANAS) and 
International Personality Item Pool (IPIP).  Personality has been shown to be 
related to successful hearing aid use.  
11. Self-efficacy, using the Generalized Self-Efficacy Scale. Self-efficacy is an 
individual’s belief in his/her ability to achieve a goal and has been linked with 
hearing device satisfaction. 
12. Working memory will be measured via the short version of the Reading Span 
Test.  Working memory is the ability to rapidly process and store information and 
has been associated with speech-in-noise recognition.  In addition, listeners with 
low working memory are thought to expend greater listening effort to understand 
speech.  It has been suggested that listeners with low working memory will 
receive greater benefit from remote microphone technology.   
13. Nine-hole peg test will be used to evaluate participants’ dexterity. 
5.0
Study Investigational Agent
The Roger Select is a remote microphone manufactured by Phonak, a subsidiary of 
Sonova (the funding group). To minimize confounding factors, participants will also be 
fit the same model and make of hearing aids (Phonak Marvel 90) for the duration of the 
trial. Both the Roger Select and the hearing aids are legally marketed devices currently 
available to consumers and and will be used in this trial accordance with its labeling, 
making this an IDE exempt regulation (21 CFR 812).   
Only current hearing aid users will be recruited for this trial and a licensed audiologist 
will fit the hearing aids and remote microphones. Devices will be programmed to 
standard clinical targets and verified using real ear measures, a standard clinical 
procedure. 
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Devices are being provided by the manufacturer, Phonak. All hearing aids and their 
accessories come with unique serial numbers. Upon receiving the devices, they will be 
evaluated for good function and serial numbers will be noted in the device log. We will 
note in the log when and to whom (using participant ID number) each individual device 
is dispensed. When a participant returns a device this will be tracked in the log, as well as 
when we return to the manufacture. 
6.0
Procedures Involved:
Approach:  The trial will use a within-subjects design consisting: 1)Baseline assessments 
(see assessments), 2) Being fit with trial hearing aids for a two week adjustment period, 
3) Roger connect fitting appointment, 3) Approximately four-week trial period of  Roger 
use in the participant’s everyday environment(s), 4) Final visit with outcome measures.
 Participants whose hearing loss qualifies them for a dome mold fitting (non-custom) will 
start their trial the same day as their eligibility assessment. Participants whose hearing 
loss or ear structure requires a custom mold fitting will have earmold impressions taken 
at their eligibility assessment and then be fit with the trial devices after the custom 
earmold has arrived back in the lab, usually about one to two weeks later. During an 
earmold impression the ear is visually inspected with an otoscope (magnifying scope with 
light). A cotton or foam block and soft impression material are placed in the ear and sets 
for approximately 3 minutes. The resulting impression is used to order an earmold for 
later testing. This is a standard clinical procedure.
 A licensed clinical audiologist will perform the assessments, fitting and counseling of 
hearing aids and Roger system, and conduct the outcome measures. To ensure 
appropriate fit and use by the participants, there will be a follow-up one week after 
receiving the Roger. During this appointment participants will be evaluated, and their 
hearing aid logging will be checked for compliance.
Hearing aid/Roger fitting:  Trial hearing aids and clinically-appropriate earmolds or 
domes will be provided by Sonova at no charge to the participants for the duration of the 
trial. The Marvel 90 hearing aids are Phonak’s advanced technology level and to provide 
datalogging via 7 base programs. Aids will be set to NAL-NL2 targets using probe 
microphone measurements. Directional microphones will be enabled and verified via 
probe-microphone testing. Roger will be verified via probe-microphone testing, 
following clinical best practice. Appropriate hearing aid adjustments (as judged by the 
study audiologist) will be permitted to provide acceptable sound quality and loudness.  
Final REARs will be recorded. Participants will be fit with the trial hearing aids and wear 
them for two weeks prior to receiving the Roger device. This is to allow participants to 
adjust to the sound quality of a new pair of hearing aids and ensure that measured 
differences are due to Roger use and not the newer hearing aids. The study audiologist 
will instruct participants regarding hearing aid and Roger device use. PHAST-R and a 
Roger competency questionnaire (to be developed with input from Phonak) will be used 
to document understanding of device function at the fitting and one-week follow-up 
appointments. Participants will then wear the hearing aids and use the Roger system for 1 
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month in their everyday listening environments. At the completion of the trial, 
participants will return to the lab for outcome assessments and to provide spontaneous 
feedback regarding their experiences. Hearing aids will be returned to the study site 
following completion of the trial.
7.0
Sharing Results with Participants
An audiologist will share and review the hearing test results with participants. They will 
also be given a copy of the test results if they so choose. 
8.0
Study Timelines
Individual Participant Timeline: Active study time for participants will be about 6 weeks, 
during which they will visit the lab at least four times: baseline+fitting of hearing aids, 
fitting of Roger, one-week follow-up, and final visit. Participants who require an earmold 
will require a two separate visits for baseline and hearing aid fitting. For these 
participants, there will be a one to two-week delay between their baseline and hearing aid 
fitting appointment while the earmold is manufactured. Visits will typically take 1-2 
hours. Some participants who require more counseling or breaks than is typical may find 
their visit durations last longer. Other participants may need to visit the lab for more 
appointments to ensure good physical and acoustic fit. Appointments will also be 
scheduled at participant’s convenience, so the duration of study stages (e.g. adjustment 
period) may vary slightly to accommodate an individual’s scheduling needs.  
Overall Study Timeline: Once enrollment begins, we hope to enroll approximately 2-3 
participants a week. Enrollment should be reached in 10 to 14 weeks. Study activities 
should then complete 6-8 weeks after that. Estimated data collection period will be 16-20 
weeks, with the possibility of an extension should recruitment prove slower than 
anticipated. Primary data analyses will take place immediately on completion of data 
collection. 
9.0
Inclusion and Exclusion Criteria:
Inclusion criteria: 
1. Adults age 18+years 
2. Speak English as their primary language 
3. Normal or corrected-to-normal vision 
4. Sensorineural hearing loss with pure-tone thresholds 20-85 dB HL at octave 
frequencies between 500 and 3000 Hz 
Current hearing aid wearer with at least 3 months of experience
Exclusion criteria:
1. Clinically significant unstable or progressive medical conditions, or conditions 
which, in the opinion of the investigator places the participant at unacceptable risk 
if he or she were to participate in the study 
2. Participants who do not pass a cognitive screening test (e.g., MoCA, MMSE or 
DRS-2)
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3. Significant history of otologic or neurologic disorders
4. Conductive hearing loss pathology or fluctuating hearing loss
No special populations will be enrolled in the study (e.g.: Adults unable to 
consent, minors, pregnant women or prisoners).
10.0
Sample Size:
Northwestern plans to enroll 40 total participants.
11.0
Research Locations:
All study tasks will take place in the Hearing Aid Lab, Northwestern’s Center for 
Audiology, Speech, Language and Learning, or the School of Communications office 
suite in Abbot Hall located on Northwestern’s downtown campus.
When testing in the Hearing Aid Lab, Frances Searle building room 1-451, we will either 
use the sound booth or lab space. All hearing related tasks take place in a sound booth 
which is a sound treated 8’x 8’ room within the larger lab space. When taking histories or 
cognitive measures we will use the office space located within the lab or an additional 
nearby (i.e. same building) testing room. The additional test room is only used if 
participant confidentiality can be maintained (i.e. conversation is not audible to those 
outside the room). When using the Center for Audiology, Speech, Language and 
Learning all tasks will take place in a sound proof booth, in a clinical Hearing Aid fit 
room, or the virtual sound environment (ViSoR). ViSoR is a 16’ by 14’ by 9’ space 
capable of simulating the acoustics and background noise properties of any environment 
by using an array of speakers. When using the Abbot Hall location, testing will take place 
in the testing suite #1700 which has been sound treated and is currently in use for clinical 
studies. Participants will be given the option to schedule appointments at the location of 
their choosing except for the final appointment. The final appointment must take place at 
the Evanston location due to equipment requirements. 
12.0
Multiple sites: 
N/A
13.0
Reliance Agreements/Single IRB:
N/A
14.0
Incomplete Disclosure or Deception:
N/A
15.0
Recruitment Methods:
Participants will be recruited from a variety of sources. 
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1. A within-laboratory participant pool of prospective participants aged 18 to 96 
years has been established by the PI.
2. Flyers posted around Northwestern University’s campus, off-campus community 
bulletin boards, and relevant online communities/message boards. 
3. Northwestern University Audiology Clinic. We plan to recruit older listeners with 
hearing loss who seek clinical care to obtain new hearing aids. Clinicians will 
receive a set of participant criteria. All patients seen for clinic appointments that 
meet the criteria and plan to be fit with one of the hearing aids predetermined to 
be of relevance to this study will be offered participation in the study.
4. Local senior centers, and local chapters of the Hearing Loss Association (HLAA). 
5. Communication Research Registry: The Communication Research Registry is a 
confidential database for individuals and families who would like to continue 
participating in research housed within Northwestern University’s School of 
Communication. These individuals sign up with the intention of being contacted 
for various research studies centered on human communication and development. 
6. Local newspaper advertisements. 
16.0
Consent Process: 
Prior to enrollment, potential participants will have a hearing and cognitive test with 
authorization by a screening consent form. These tests will allow us to exclude potential 
participants from enrolling in the study who are ineligible based upon their hearing or 
cognitive status. These 45-minute tests are built into the study design of visit 1 tasks and 
do not require additional visits. If a participant is not eligible to participate based upon 
the screening consent, they can authorize future contact with the consent’s optional 
element and authorize the lab to retain the screening audiogram. If participant is eligible 
based upon their screening results, they will be enrolled in the study with separate 
consent. Some participants recruited from our participant database may have already 
passed the eligibility screening assessments and indicated their wish to be considered for 
other studies may be contacted. Should these participants decide this study is of interest 
to them, they will not need to repeat these measures and will proceed to the full consent 
form. All participants will provide their consent to study procedures to the investigator 
or her research assistants. This process will take place in the Hearing Aid Laboratory, 
prior to any research procedure taking place. All consent forms are stored in a locked 
file cabinet drawer within the Hearing Aid lab (a locked laboratory). An unlimited 
amount of time will be provided to the participant to ensure they have adequately 
reviewed the consent form and all questions have been addressed by study staff. 
Following the participant’s opportunity to read the consent document, study staff will 
review each section with participant to clarify the study or any procedure and ensure 
understanding. Additionally, consent forms may be provided to a potential research 
participant before a study visit is scheduled so they may take extra time to review before 
committing to participation. All participants will receive a copy of their signed consent 
form. We will give participants the option of being audio and/or video recorded during 
this experiment (for both screening and data collection). The objective of this recording 
is to be able to have internal lab staff reliability discussions to ensure test reliability and 
accuracy. When recorded, participant anonymity will be maintained (i.e. name is not 
being said, face is not recorded, hands are being recorded if possible). Participants will 
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document on the consent forms whether or not they agree to being recorded, or if 
recording is not applicable for a specific experiment. Recordings will be kept and used 
for lab staff only and will be destroyed once data analysis is complete. 
17.0
Financial Compensation:
Upon completion of study tasks, participants will be paid an hourly rate for participation 
($15/hr). Payment will be made in cash at the conclusion of each study visit. If a subject 
decides to withdraw from the study before its completion, s/he will still be paid $15 per 
hour for the time spent. In the event that a participant is removed from the study without 
their consent, compensation will be pro-rated based upon the duration the participant 
remained compliant with study tasks and procedures. Participants who remain enrolled 
through the entire duration of the study will receive a $50 completion bonus.  
18.0
Audio/Video Recording/Photography
We will give participants the option of declining to being audio recorded during this 
experiment (for data collection). The objective of this audio recording is to be able to 
have internal lab staff reliability discussions to ensure test reliability and accuracy. 
When recorded, participant anonymity will be maintained (i.e. name is not being said, 
filename is de-identified). Participants will document on the consent forms whether or 
not they agree to being recorded, or if recording is not applicable for a specific 
experiment. Recordings will be kept and used for lab staff only and will be destroyed 
once data analysis is complete.
19.0
Potential Benefits to Participants: 
Although participants in this study may not directly benefit from participation, many 
people are attracted to hearing aid research as an opportunity to learn about their hearing 
and ask questions about hearing aids and assistive listening devices (such as a remote 
microphone) without sales pressure. Participants who had been unaware of remote 
microphones or unsure if they would benefit may find the study helps them determine if 
it is something they would like to pursue with their hearing health provider. All 
participants in the study will have the opportunity to receive counseling at the end of the 
study, done by the investigator, including listening recommendations tailored to their 
individual speech understanding, memory and attention. They will have a chance to ask 
questions and receive information about options for their hearing loss (outside of the 
study).
20.0
Risks to Participants:
All study procedures pose minimal risk to study participants. Some of the study tasks can 
be boring, or repetitive. If a participant wishes to discontinue testing at any point they 
may choose to do so without any consequence. Additionally, listeners who receive poor 
scores on the attention and memory tests may be disappointed to learn of their 
performance. There is a possibility that some people may find some of the questionnaires 
uncomfortable. Participants will be told they do not need to answer any question or 
questions that make them uncomfortable. Participants will not be removed from the study 
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for declining to answer part of all of the questionnaires. Some participants may find the 
hearing aid settings used in this study to be loud or sharp in comparison to their own 
hearing aid settings. These are all normal and expected consequences of new hearing 
aids.
If an earmold impression is taken, participants may experience some temporary 
discomfort or a ticklish feeling as the cotton or foam block is placed into the ear canal. 
Participants may also notice that the impression material is slightly cold, or experience a 
feeling of pressure while the impression material is in your ear. Rarely, there can be some 
minor abrasions to the skin of the ear canal. These procedures are routinely used when 
fitting hearing aids or creating custom earplugs and the risks in this study are no higher 
than the risks that would be experienced in an audiology clinic. 
If the investigator determines participation in the study places a subject at an 
unacceptable level of risk, enrollment or study tasks will not proceed. 
If a research participant decides to withdraw or discontinue study procedures all data 
collected up to that point can be used by the investigator unless the participant indicates 
they would like to have their data removed from the study. Once a participant is unable to 
continue with the study, compensation will end. 
21.0
Provisions to Protect the Privacy and Confidentiality of 
Participants and the Research Data:
During the consent process a lab member will explain that their identifiable 
information will not be used. Each participant will receive a study code that will 
be used for all study data. The only link between identifiable data and a study 
code will be on a password protected HIPAA-approved server with server 
security managed by Northwestern School of Communication computer staff. 
Any physical data containing identifiable participant information (i.e. consent 
documents) are kept under lock and key accessible only by study staff. 
22.0
Data Monitoring Plan to Ensure the Safety of Participants:
N/A
23.0
Data, and if applicable, Specimen Banking: 
N/A
24.0
Data Sharing:
This project is funded by Sonova and data may be shared with their research staff for the 
purposes of developing better fitting protocols for remote microphones. Any data shared 
will be de-identified. Physical files in our lab are kept in a locked filing cabinet. Any data 
stored electronically is de-identified. 
25.0
Qualifications of Research Team to Conduct the Research:
The Principle Investigator, Pamela Souza, PhD, CCC-A, FAAA, is a licensed audiologist 
and an experienced researcher at Northwestern University. Kendra Marks, Au.D., is a 
licensed audiologist with clinical and research experience. 
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IRB #: STU00209649 Approved by NU IRB for use on or after 2/14/2020 through 2/13/2021.