Evaluation of the Baha SoundArc in Pediatric Patients
Phase: NA
Conditions: Hearing Loss, Conductive, Hearing Loss, Mixed, Hearing Loss, Unilateral
Sponsor: Cochlear

   
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CAM-CL-111_F  
 
 
 
PROTOCOL 
 
Evaluation of the Baha SoundArc in  
Pediatric Patients 
 
Investigation Number:  
CAM5714 
_______________________ 
   
Version 1.0 
August 18, 2017 
_______________________ 
Study Sponsor: 
 
Cochlear Americas 
13059 E. Peakview Avenue, 
Centennial, CO 80111 
 
 
CONFIDENTIAL – DO NOT COPY 
This document contains information that is confidential and proprietary to Cochlear. 
This information is being provided to you solely for the purpose of evaluating or 
conducting a clinical study for Cochlear. You may disclose the contents of this 
document only to study personnel under your supervision who need to know the 
contents for this purpose and to your Institutional Review Board (IRB); the contents 
of this document may not be disclosed without the prior authorization from Cochlear. 
The foregoing shall not apply to disclosure required by governmental regulations or 
laws. Any supplemental information that may be added to this document also is 
confidential and proprietary to Cochlear and must be kept in confidence in the same 
manner as the contents of this document. 

   
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Investigator Responsibilities 
I, the undersigned, am responsible for the conduct of the study at the site below 
and by my signature below, I confirm that I have read, understand and will strictly 
adhere to the study protocol, “Evaluation of the Baha SoundArc in Pediatric 
Patients.” 
 
 
Clinical Investigational Site 
 
 
Primary Investigator’s Name (print) 
 
 
Title 
 
 
Signature 
 
 
Sponsor Representative 
 
 
Title 
 
 
Signature 
 

   
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Table of Contents 
1.0 
Clinical Synopsis ............................................................................................... 5 
2.0 
Glossary ............................................................................................................ 7 
3.0 
Introduction and background ............................................................................ 8 
3.1 
Study Objective ................................................................................................. 9 
4.0 
Criteria for Subject Selection ............................................................................ 9 
4.1 
Inclusion Criteria ............................................................................................... 9 
4.2 
Exclusion Criteria .............................................................................................. 9 
5.0 
Methods and Procedures .................................................................................. 9 
5.1 
Device description............................................................................................. 9 
5.2 
Description of Test Measures ........................................................................... 9 
5.2.1 
PBK Word Recognition Test ............................................................................. 9 
5.2.2 
Audiometric Sound Field Threshold Test Aided .............................................. 10 
5.2.3 
Unscheduled Visit ........................................................................................... 10 
5.3 
Summary of Data Collection Visits .................................................................. 10 
5.3.1 
Visit 1 .............................................................................................................. 10 
5.3.2 
Visit 2 .............................................................................................................. 10 
5.4 
Data Analyses ................................................................................................. 10 
5.4.1 
Sample Size .................................................................................................... 10 
5.4.2 
Missing Data ................................................................................................... 10 
5.4.3 
Access to Study Documents and Data Monitoring .......................................... 11 
5.5 
Data Storage and Confidentiality .................................................................... 12 
5.5.1 
Confidentiality ................................................................................................. 12 
5.5.2 
Subject Identification ....................................................................................... 12 
5.5.3 
Release of Medical Information ...................................................................... 12 
6.0 
Risk Benefit Statement ................................................................................... 12 

   
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6.1 
Risk Category ................................................................................................. 12 
6.2 
Potential Risk and Protection against Risks .................................................... 13 
6.3 
Potential Benefits to Subjects ......................................................................... 13 
6.4 
Alternatives to Participation ............................................................................ 13 
7.0 
Subject identification, Recruitment, and Consent/Assent................................ 13 
7.1 
Method of Subject Identification and Recruitment ........................................... 13 
7.2 
Process of Consent......................................................................................... 13 
7.3 
Subject Capacity ............................................................................................. 14 
7.4 
Subject/Representative Comprehension ......................................................... 14 
7.5 
Consent Forms ............................................................................................... 14 
7.6 
Documentation of Consent ............................................................................. 14 
7.7 
Costs to the Subject ........................................................................................ 14 
7.8 
Payment for Participation ................................................................................ 14 
7.9 
Institutional Review Board .............................................................................. 15 
8.0 
References ..................................................................................................... 16 
 
 

   
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 Clinical Synopsis  
Investigation title  Evaluation of the Baha SoundArc in Pediatric Patients 
Total expected 
duration of the 
clinical 
investigation  
4 to 6 weeks  
Enrollment period  
 
Existing subjects fitted with Baha sound processor on Softband for a 
minimum of three months 
Expected duration 
per subject  
Up to 6 weeks 
Investigational 
design  
The clinical investigation will be conducted as a nonrandomized, 
single-subject, repeated-measures design in which each subject 
serves as his/her own control.  
Number of 
subjects  
Up to 30 total subjects 
Number of 
investigational 
sites  
Up to 3 sites  
Inclusion Criteria 
• 
Existing recipients using a Baha sound processor on a 
Softband for at least three months 
• 
Subjects aged 5 through 12 years of age 
• 
Subjects should be able to perform clinical testing adapted 
for age and developmental status, (Threshold sound field 
audiometry and basic monosyllabic word test, PBK) 
• 
Willingness on behalf of the subject’s parent or guardian to 
complete study questionnaire 
Exclusion criteria  
• 
 Subject’s inability to perform requisite test measures as 
described in the study protocol 
Primary objective  
• 
To evaluate patient experience when using the Baha 
SoundArc after a one month take-home trial, compared to 
the existing Baha Softband on the Participant Take Home 
questionnaire   

   
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Primary endpoint  
• 
Patient experience for the Baha SoundArc will be the 
same or better for the majority of participants (75% or 
greater) 
Additional 
analyses 
• 
To characterize clinician satisfaction of the fitting and use 
of the Baha SoundArc 
• 
To characterize speech perception on the PBK word 
recognition test in quiet when using the Baha SoundArc 
after 1 month of experience   
• 
To characterize aided thresholds using the SoundArc 
when compared to the Baha Softband 
Investigation 
schedule  
  
Visit 1:  
• 
Description of Study to Subject or Subject’s 
parent/guardian  
• 
Informed Consent 
• 
Measurement of Audiometric thresholds and PBK word list 
(1 list) with the subject’s Baha Sound processor on a 
Softband in Sound field  
• 
Fitting and adjustment of the Baha SoundArc 
• 
Orientation and instruction for use in preparation for the 
take home trial   
 
Visit 2: 
• 
Measurement of Audiometric thresholds and PBK word list 
(1 list) with the subject’s Baha Sound Processor on the 
SoundArc in Sound field 
• 
Completion of the subject/parent questionnaire on the 
experience of use of the Baha SoundArc using the Subject 
Take Home questionnaire  
• 
At the conclusion of study, clinician(s) will complete a 
questionnaire detailing the usability, functionality and 
preferences using and fitting the Baha SoundArc 
 

   
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 Glossary 
Term 
Definition 
AE 
Adverse Event 
IRB 
Institutional Review Board 
CRF 
Case Report Form 
SAE 
Serious Adverse Event 
PBK 
Phonetically Balanced Kindergarten word list  
Baha Sound Processor 
Bone Conduction sound processor 
Baha Softband 
Non-surgical connection method for use with Baha 
Sound processor fitted to an elastic fitted band 
Baha SoundArc 
Non-surgical connection method for use with a 
Baha Sound processor fitted to a wire arc (behind 
the head), adjustable for head size and comfort 
Subject Questionnaire 
Questionnaire to be completed by subject or 
subject’s parent or guardian describing the 
experience of Baha SoundArc use during the take-
home trial 
Clinician Questionnaire 
Questionnaire to be completed by the fitting 
clinician(s) describing the usability, function and 
preferences using the Baha SoundArc 
 
 
 

   
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 Introduction and background 
The Baha SoundArc coupling system has been developed as a non-surgical coupling of a 
Baha sound processor to the skull allowing the transfer of vibrational energy to the cochlear 
partition via bone conduction pathways. Today we offer two alternatives to this non-surgical 
approach; the Baha headband/test band and the Baha Softband. Each of these current options 
have benefits and liabilities.  In the liability column, there is comfort and cosmetic concerns to 
consider. In the benefits column, there is need to provide a vehicle to test a potential candidate 
with a bone conduction system prior to making final decisions regarding implantation of the 
Baha system. There is also a population (under 5 years) where a need exists for Bone 
conduction amplification. Current approved clearance is for children 5 years and older. This is 
due to less mature bone substrate and the act of osseointergration. There is also in a more 
limited group, a need for a non-surgical option for use of the Baha Bone conduction sound 
processor in candidates that cannot or will not accept a surgical implant. 
Currently, persons in need of this non-surgical coupling of a Baha sound processor had only to 
choose between the Headband/Test Band that is a spring steel appliance that holds the 
vibrating Baha sound processor in contact with the skull to access the bone conduction 
pathway. Use of this appliance is acceptable in short-term wearing conditions but in practice is 
not always comfortable for long-term wear. In addition to wearing comfort, there are often 
cosmetic objections to wearing this appliance long-term. A more comfortable option is the 
Baha Softband, which is a latex-free elastic strap that contains a size adjustment buckle, a 
safety break-away connector and a force contact point where the Baha sound processor 
attaches. The original design intention of the Baha Softband was in the pediatric population.  
Older children and adults can also use this method of coupling. However, the Softband has a 
negative cosmetic appeal in this older child to adult patient pool. 
Due to the cosmetic and comfort issues, the team at Cochlear Bone Anchored Solutions 
(CBAS) has produced the Baha SoundArc seen below. 
 
 
 
                                 

   
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 Study Objective 
To evaluate patient experience when using the Baha SoundArc after a one month take-home 
trial, compared to the existing Baha Softband on the Participant Take Home questionnaire in a 
group of 30 pediatric subjects. 
 Criteria for Subject Selection 
Cochlear Americas expects to enroll up to 30 patients at up to 3 North American Baha implant 
centers. The duration of the multi-site study is expected to be up to 2 months, depending on 
subject recruitment.   
 Inclusion Criteria 
Subjects will have been fitted with the Baha Sound processor on a Softband for a minimum 
of 3 months:  
o Aged 5 to 12 years of age 
o Subjects should be able to perform clinical testing adapted for age and 
developmental status (threshold sound field audiometry and basic monosyllabic 
word tests) 
o Willingness on behalf of the subject’s parent or guardian to complete study 
questionnaire 
 Exclusion Criteria 
Subject’s inability to perform requisite test measures as described in the study protocol 
 Methods and Procedures  
 Device description  
Cochlear™ Baha sound processors to be used in this study may include commercially 
available Baha 3, Baha 4, or Baha 5 series processors. These devices need to have been 
previously fitted and worn by the subject for a minimum of three months on a Baha Softband.   
 Description of Test Measures 
 PBK Word Recognition Test 
The PBK Word Test (Haskins, 1949) is a validated test used clinically and in research to 
assess the speech perception performance of individuals with hearing aids, cochlear implants, 
and bone anchored devices on open-set word recognition. The test consists of 4 recorded lists 
of 50 monosyllabic words in CD format. For this study, one list will be administered in quiet at a 
level equal to 60dBA in the sound field and scored as total number of words correct, which will 

   
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be expressed as a percentage correct for this study. Subjects will be tested using a 
configuration of speech at 0º azimuth in quiet. The non-test ear will be plugged for testing. 
 Audiometric Sound Field Threshold Test Aided 
The Audiometric Sound Field Threshold Test will be carried out using narrow band noise 
stimuli at audiometric frequencies, 250Hz, 500Hz, 1000Hz, 2000Hz, 3000Hz, and 4000Hz 
using standard methods for threshold measurement that may be adapted for age and 
developmental level.  The non-test ear will be plugged. 
 Unscheduled Visit 
If a subject requires an interim clinical visit, an Unscheduled Visit Form will be completed. 
Information collected will include reason for visit, activities completed and visit date.  
 Summary of Data Collection Visits 
  Visit 1:  
o Description of Study to Subject or Subject’s parent/guardian  
o Informed Consent 
o Measurement of Audiometric thresholds and PBK word list (1 list) with the 
subject’s Baha Sound processor on a Softband fitting in Sound field  
o Fitting and adjustment of the Baha SoundArc 
o Orientation and instruction for use in preparation for the take-home trial 
  Visit 2:  
o Measurement of Audiometric thresholds and PBK word list (1 list) with the 
subject’s Baha Sound Processor on the SoundArc in Sound field 
o Completion of the subject/parent questionnaire on the experience of use of the 
Baha SoundArc using the Subject Take Home questionnaire  
o At the conclusion of study, clinician(s) will complete a questionnaire detailing the 
usability, functionality and preferences using and fitting the Baha SoundArc 
 Data Analyses 
 Sample Size 
Thirty pediatric subjects will be consented to participate in this study across 3 large pediatric 
centers.   
 Missing Data  
All efforts will be put forth to ensure near complete follow-up, with particular focus on the 
assessment of the primary outcome and occurrence of adverse events. Regular reminders of 
subject follow-up due dates will be provided to participating centers to facilitate scheduling of 
follow-up visits. 

   
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 Access to Study Documents and Data Monitoring 
Investigator(s) will provide access to study documentation including source data for the 
purposes of monitoring, audits, IRB review, and regulatory inspections. 
The Sponsor will designate appropriately trained monitors to review the progress of this study 
and assure the quality and integrity of data accumulated. Clinical monitors, as representatives 
of the Sponsor, have the obligation to provide site qualification and initiation visits as well as 
regular site visits. The study monitors will be employees of the Sponsor, Cochlear Americas, or 
any contracted vendors qualified by experience and training to conduct study site monitoring 
for this investigation. Study monitors, employed by Cochlear Americas, for this study will be: 
 
Lori O’Neill, AuD 
 
 
 
 
Aaron Parkinson, PhD 
Cochlear Americas   
 
 
 
Cochlear Americas 
13059 E. Peakview Ave.   
 
 
13059 E. Peakview Ave. 
Centennial, CO 80111  
 
 
 
Centennial, CO 80111 
 
Kimberly Nix, AuD  
 
 
 
Megan Mears, AuD 
Cochlear Americas   
 
 
 
Cochlear Americas 
13059 E. Peakview Ave. 
 
 
 
13059 E. Peakview Ave. 
Centennial, CO 80111  
 
 
 
Centennial, CO 80111 
 
Shanell Laner 
 
 
 
 
Heather Ottum 
Cochlear Americas   
 
 
 
Cochlear Americas 
13059 E. Peakview Ave. 
 
                      13059 E. Peakview Ave. 
Centennial, CO 80111  
 
 
 
Centennial, CO 80111 
 
Ginger Grant, AuD  
 
 
 
 
 
 
 
Cochlear Americas   
 
 
 
 
13059 E. Peakview Ave. 
 
 
 
 
Centennial, CO 8011 
 
 
 
 
 
 
 
 
 
 
 
All data generated during this study and the source documents from which they originated are 
open to inspection by the Sponsor or its representative, and other regulatory agencies. Upon 
completion of the study, the clinical monitor will conduct a final visit, or close-out of the site. 
The objectives of this visit are to ascertain that all subjects are accounted for, that the 
regulatory records and reports are complete, verify that study device and other supplies have 
been accounted for and ensure that the Investigator is aware of his/her responsibilities post-
study. 

   
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 Data Storage and Confidentiality  
 Confidentiality 
A Case Report Form (CRF) will be completed for each study subject, summarizing all clinical 
and study data. The CRF contains confidential material. Subjects will only be referred to in the 
CRF by their subject numbers in order to retain subject confidentiality. Specific instructions to 
complete the CRF shall be provided to the clinical investigation team as appropriate. 
Copies of the completed CRFs are to be provided to the Sponsor as soon as practical after 
completion and review. The original CRFs are to be retained by the Investigator for a period of 
time as determined by local regulations. 
 Subject Identification 
To maintain confidentiality, the subject’s name will not be recorded on any study document 
other than the informed consent form. All individuals who provide informed consent (sign the 
informed consent form) are considered consented into the study and will be assigned a unique 
identifier. A unique alphanumeric code will identify the subject throughout the course of the 
study. For example, US01-ARC-0000, where: 
• US = United States 
• 01 = a sequential numeral corresponding the order in which a subject is enrolled into the 
study for a given study site, in this case this would correspond to the first subject 
recruited into the study for a particular site, 
• ARC = an abbreviation for the study, in this case “ARC” for the Baha SoundArc, 
• 0000 = a unique, numeric study site identification. 
 Release of Medical Information 
Subjects will be required to release the exchange of medical information between the 
Investigator(s) and the Sponsor. This requirement will be clearly identified in the Informed 
Consent form.  
 Risk Benefit Statement 
It is possible but not guaranteed that advances in Baha technology will improve performance 
via use of the Baha SoundArc. This clinical investigation will help to inform the future 
development of associated clinical guidance when fitting Baha patients.  
 Risk Category 
As determined by the Sponsor, this study has been designated as non-significant risk. The 
Baha Softband/SoundArc, and sound processor used in this study are commercially cleared by 
the Food and Drug Administration (FDA) and is considered standard of care.  

   
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 Potential Risk and Protection against Risks  
Subjects may experience discomfort while using the Baha SoundArc.  This could include, 
pressure at the temple piece, rash or itching.  These issues are usually resolved by adjustment 
of the position and tension of the SoundArc bow.  
 Potential Benefits to Subjects 
Potential benefits to subjects may include improved wearing experience when using the Baha 
SoundArc. It cannot be promised that subjects will receive any medical benefits from 
participating in this study.  
 Alternatives to Participation  
In lieu of study participation, patients may elect to continue standard clinical care and use of 
their Baha Sound Processor on the Baha Softband.  
  Subject identification, Recruitment, and Consent/Assent  
 Method of Subject Identification and Recruitment  
Subjects will be recruited into the study sequentially to ensure a subject pool representative of 
the general population of those with hearing loss, with no pre-selection based on age (other 
than being between  5 and 12 years-of-age), ethnicity or gender as described in Section 2.0. 
The identification and recruitment of subjects will protect patient privacy and be free of undue 
influence.  
 Process of Consent  
Prior to recruitment of any subjects into the study, written approval of the investigational plan 
including clinical protocol and informed consent form will be obtained from reviewing 
Institutional Review Board (IRB). An interview (as part of the informed consent process) will be 
conducted by the surgeon and/or audiologist to inform the subject about rationale for and the 
details, aims, objectives of the study, study expectations, evaluation schedule, and the risks 
and benefits of the trial treatment (and alternative treatments), and the extent of the patient’s 
involvement. Written informed consent shall be obtained from each subject after this 
explanation. After reviewing the Informed Consent Form, the subject will be given the 
opportunity to review and ask questions about the Informed Consent Form and/or the study 
prior to signing the Informed Consent Form. The subject will be offered the opportunity to take 
the form home to discuss with family members should they choose to do so. If they sign the 
Informed Consent Form, the subject twill then be given a copy of the signed Informed Consent 
Form to take home.   
 

   
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The Investigator is responsible for ensuring that all patients give written informed consent prior 
to any study-related examination or activity. All patients shall sign and date the Informed 
Consent Form, and a copy of the Informed Consent Form shall be given to the patient. The 
Sponsor and the Investigator(s) shall avoid improper influence on or inducement of the subject, 
monitor, the Investigator(s) or other parties participating in or contributing to the clinical 
investigation.  
 Subject Capacity  
Subjects participating in this study will have the capacity to provide informed consent as 
assessed by the Investigators. The only anticipated exception this is minors, for which assent 
will be obtained in addition to parental consent.  
 Subject/Representative Comprehension  
 Consent Forms  
The informed consent form provided for this study will meet requirements for specific sections 
as described in 21 CRF 50.25.  
 Documentation of Consent 
A subject is not considered enrolled until a properly executed Informed Consent Form has 
been obtained and inclusion/exclusion information has been reviewed and approved by 
Cochlear Americas, as evidenced by the return of a study approval form signed by a Cochlear 
Americas representative.  
 Costs to the Subject 
There will be no cost to the study subjects participating in this study. 
 Payment for Participation  
Subjects will be paid $12.50/hour for study visits completed. If a subject withdraws from the study 
before completing all study visits, they will be compensated $12.50/hour for the study visits which 
were completed. In order to receive payment for participation, subjects will need to complete a 
W-9 form, which is required because study payments for time are taxable. 
Subjects will be paid for transportation to and from the study visits at a rate of .52 cents per mile 
from home to visit and return. Reimbursement for parking on the day of the study visit will also 
be provided.   
 

   
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 Institutional Review Board 
Each site will obtain approval from its designated IRB prior to commencing any study-related 
activities. A copy of the IRB approval will be kept in the Investigator file(s). Any additional 
requirements imposed by the IRB and/or regulatory authority shall be followed. The 
Investigator(s) will submit the appropriate documentation if any necessary extension or 
renewal of the IRB approval must be obtained. 
Study procedures will not be changed without mutual agreement between the Sponsor and the 
Investigator(s). Changes will be implemented in a signed protocol amendment, and for 
significant changes, approval will be obtained from the IRB.  
 
 
 
 
 
 
 
 

   
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 References 
Haskins, H. A., (1949) A phonetically balanced test of speech discrimination for children, 
Unpublished master’s thesis. Northwestern University, Evanston, IL, USA.