Iowa Cochlear Implant Clinical Research Center Hybrid Cochlear Implants in Severe to Profound Adults, Children, and Adolescents
Phase: NA
Conditions: Hearing Loss, High-Frequency
Sponsor: Bruce J Gantz

Iowa Cochlear Implant Clinical Research Center Hybrid Cochlear Implants in Severe to Profound Adults, 
Children, and Adolescents 
 
 
9/2011 Protocol approved by FDA (modification) 
177
ATTACHMENT 3 
Investigational Protocol:  Iowa Cochlear Implant Clinical Research Center Hybrid 
Cochlear Implants in Severe to Profound Adults, Children, and Adolescents 
 
1 
INVESTIGATIONAL PROTOCOL  
The purpose of this study is to determine if individuals with residual low-frequency hearing in 
the severe range can develop improved speech perception by combining their residual 
acoustic hearing with electrical processing through a cochlear implant designed to stimulate 
the high-frequency basal and middle turn of the cochlea while preserving useful low-
frequency acoustic hearing.  To accomplish this, we propose to implant individuals with 
severe hearing with a Cochlear® Nucleus™ Hybrid L24 Implant or a Cochlear® Nucleus™ 
Hybrid S12 in the poorer ear. We believe these devices will do less damage to the Organ of 
Corti structures, than longer, more invasive standard cochlear implant electrodes.  Two 
different populations will be studied under this IDE. 
Population 1: 15 Adults who have a severe sensorineural hearing loss with a pure-tone 
average (PTA) between 60-90 dB HL between 125-1500 Hz and profound loss at higher 
frequencies will be implanted with the Cochlear® Nucleus™ Hybrid L24 Implant. The 
potential subject will present with Consonant-Nucleus-Consonant (CNC) monosyllabic word 
scores between 0-35% in the ear to be implanted and up to 60% understanding in the 
contralateral ear in the best-aided condition.  
Population 2:  30 Children (ages 5-12 years) and adolescents (ages 13-15 years) who have 
a sensorineural hearing loss with a pure-tone average (PTA) between 70-90 dB HL between 
125-1500 Hz and profound loss at higher frequencies will be implanted with the Cochlear® 
Nucleus™ Hybrid L24 Implant or the Cochlear® Nucleus™ Hybrid S12 Implant. Those that 
have hearing thresholds between 70-90 dB HL at 1500 Hz would be implanted with the less 
invasive shorter 10 mm Hybrid S12 in attempt to better preserve the middle frequency 
range.  Those with hearing thresholds >90 dB HL at 1500 Hz would receive the longer 16 
mm Hybrid L24 electrode.  The potential subject will present with Phonetically Balanced 
Kindergarten (PB-K) monosyllabic word scores between 0-50% in the ear to be implanted 
and up to 60% understanding in the contralateral ear in the best-aided condition. 
Through the preserved acoustic hearing, we believe the subject will experience better signal 
to noise ratios for speech perception in noise, better localization of sound and an 
improvement music perception.  Histological evidence from patients implanted with standard 
arrays and our experience with a short electrode array for implantation of individuals with 
significant residual hearing both support this assumption (Nadol, Shiao, Burgess, Ketten, 
Eddington et al., 2001).  The duration of this study will be 2 years (24 months) for adults and 
for 5 years (60 months) in children and adolescents. 
1.1 
Criteria for Inclusion in Population 1 
Criterion for selection will be subject interest in preservation of residual hearing; severe 
sensorineural hearing loss; lack of benefit from appropriately fit binaural hearing aids worn 
on a full-time basis; and realistic expectations.  Qualified participants must also meet the 
following criteria for inclusion: 
1. 
Eighteen year of age or older at the time of implantation. 
2. 
Severe sensorineural hearing loss with a pure-tone average (PTA) between 60-90 dB 
HL between 125-1500 Hz and profound loss at higher frequencies in the ear to be 
implanted. 

Iowa Cochlear Implant Clinical Research Center Hybrid Cochlear Implants in Severe to Profound Adults, 
Children, and Adolescents 
 
 
9/2011 Protocol approved by FDA (modification) 
178
3. 
Speech Perception: 
a. The Consonant-Nucleus-Consonant (CNC) word recognition score between 
0% and 35% inclusive (i.e., 0% ≤ score ≤ 35%) in the ear to be implanted. 
b. The CNC word recognition score in the contralateral ear equal to or better 
than, in the ear to be implanted but not more than 60% in the best-aided 
condition. 
4. 
English spoken as a primary language. 
5. 
Willingness to comply with all study requirements. 
6. 
Minimum of 30 day hearing aid trial with appropriately fit hearing aids worn on a full-
time basis (8 hours per day). 
7. 
Patent cochlea and normal cochlear anatomy. 
1.2 
Criteria for Inclusion in Population 2 
Criterion for selection will be parent interest in preservation of residual hearing; severe post-
lingual onset of sensorineural hearing loss; lack of benefit from appropriately fit binaural 
hearing aids worn on a full-time basis; and supportive family dynamics.  Qualified 
participants must also meet the following criteria for inclusion: 
1. Five to fifteen years of age at the time of implantation. 
2. Severe sensorineural hearing loss with a pure-tone average (PTA) between 70-90 dB 
HL between 125-1500 Hz and profound loss at higher frequencies in the ear to be 
implanted. 
3. Speech Perception: 
a. The Phonetically Balanced-Kindergarten (PB-K) word recognition score 
between 0% and 50% inclusive (i.e., 0% ≤ score ≤ 50%) in the ear to be 
implanted. 
b. The PB-K word recognition score in the contralateral ear equal to or better 
than, in the ear to be implanted but not more than 60%. 
4. English spoken as a primary language. 
5. Willingness to comply with all study requirements. 
6. Minimum of 30-day hearing aid trial with appropriately fit hearing aids worn on a full-time 
basis (8 hours per day).. 
7. Patent cochlea and normal cochlear anatomy. 
8. Must be in a habilitation/educational program with an emphasis on spoken language 
development. 
1.3 
Criteria for Exclusion in Populations 1 and 2 
1. 
Medical or psychological conditions that contraindicate undergoing surgery. 
2. 
Ossification or any other cochlear anomaly that might prevent complete insertion of the 
electrode array.  
3. 
Unrealistic expectations on the part of the candidate and/or candidate’s family, 
regarding the possible benefits, risks, and limitations that are inherent to the surgical 
procedure(s) and prosthetic devices. 

Iowa Cochlear Implant Clinical Research Center Hybrid Cochlear Implants in Severe to Profound Adults, 
Children, and Adolescents 
 
 
9/2011 Protocol approved by FDA (modification) 
179
4. 
Unwillingness or inability of the candidate to comply with all investigational 
requirements. 
5. 
Active middle ear infection. 
2 
Investigational Procedure 
2.1 
Design Overview 
The study will be conducted as a repeated-measure, single-subject experiment.  A single-
subject research design (in which each subject serves as his or her own control) is 
appropriate since it accommodates the heterogeneity that characterizes hearing-impaired 
populations.  Blinding or masking procedures are not included in the design, as it is not 
possible to conceal the presence or absence of a cochlear implant from device recipients 
and/or clinical investigators. 
Preoperatively, candidates will be assessed with their current amplification to evaluate their 
appropriateness for entrance into the study.  The candidate’s audiometric configuration and 
speech perception must meet the above inclusion criteria.  Prior to any speech perception 
testing taking place, the appropriateness of the hearing aid fitting will be assessed (see 
below for further details) and adjustments made if necessary.  In cases where amplification 
has not been used for more than one year, new hearing aids will be fitted, worn for a 
minimum 30-day trial period and the subjects re-evaluated to confirm continuance with the 
study.  
Fifteen adults who have a severe sensorineural hearing loss with a pure-tone average (PTA) 
between 60-90 dB HL between 125-1500 Hz and profound loss at higher frequencies will be 
implanted with the Cochlear® Nucleus™ Hybrid L24 Implant. The potential subject will 
present with Consonant-Nucleus-Consonant (CNC) monosyllabic word scores between 0-
35% in the ear to be implanted and up to 60% understanding in the contralateral ear in the 
best-aided condition.  
Fifteen children (ages 5-12 years) and adolescents (ages 13-15 years) who have a 
sensorineural hearing loss with a PTA between 70-90 dB HL between 125-1500 Hz, a 
hearing threshold >90 dB HL at 1500 Hz, and profound loss at higher frequencies will be 
implanted with the Cochlear® Nucleus™ Hybrid L24 Implant. In addition, in attempt to better 
preserve the middle frequency range, fifteen children (ages 5-12 years) and adolescents 
(ages 13-15 years) who have a sensorineural hearing loss with a pure-tone average PTA 
between 70-90 dB HL between 125-1500 Hz, a hearing threshold ≤90 dB HL at 1500 Hz, 
and profound loss at higher frequencies will be implanted with the Cochlear® Nucleus™ 
Hybrid S12 Implant.  All potential subjects will present with Phonetically Balanced 
Kindergarten (PB-K) monosyllabic word scores between 0-50% in the ear to be implanted 
and up to 60% understanding in the contralateral ear in the best-aided condition. 
Postoperatively, electric alone, hybrid, and combined listening (i.e., electric and acoustic 
together) modes will be compared to evaluate the usefulness of adding the electric 
stimulation while preserving residual hearing for acoustic stimulation. The following defines 
the various modes referenced throughout the course of this text: 
Acoustic Stimulation: Use of the word “acoustic” refers to sound only delivered with 
amplification. 
Electric Stimulation: Use of the word “electric” refers to sound delivered via a cochlear 
implant only. 
Hybrid Stimulation: Use of acoustic hearing, with amplification, in addition to electric hearing 
via a cochlear implant in the same ear. 

Iowa Cochlear Implant Clinical Research Center Hybrid Cochlear Implants in Severe to Profound Adults, 
Children, and Adolescents 
 
 
9/2011 Protocol approved by FDA (modification) 
180
Combined Stimulation: Use of acoustic hearing bilaterally, with amplification, in addition to 
electric hearing via a cochlear implant.   
2.2 
Device Description 
Nucleus Hybrid 24 cochlear implant 
The Nucleus Hybrid L24 cochlear implant system comprises: 
• 
Nucleus Hybrid L24 cochlear implant, 
• 
Nucleus Freedom™ for Hybrid sound processor or Nucleus Hybrid SP, and 
• 
Nucleus Custom Sound™ programming software. 
The Nucleus Hybrid L24 cochlear implant incorporates an electrode array designed to 
preserve residual hearing. This has been accomplished by employing a thin, straight, 
intracochlear electrode array attached to a Nucleus cochlear implant receiver/stimulator (the 
same as currently used in the approved Nucleus Freedom™ cochlear implant system 
P970051/S028). The Nucleus Hybrid L24 array has 22 electrodes spread over 16 mm and 
an anticipated insertion depth of 16 mm. It is slim, with its dimensions ranging from 0.35 x 
0.25 mm (at the tip) to 0.55 x 0.4 mm, and designed to minimize lateral wall forces with a 
stiffened basal section to prevent buckling. A winglet is attached to the electrode lead to 
allow a better handling of the electrode array and to avoid over insertion. The electrode 
array also incorporates a collar to prevent over-insertion, or further migration, into the 
cochlea. The resultant insertion angle is about 280-300° in the scala tympani for the Hybrid 
L24, as confirmed in temporal bone trials at the Medical University Hannover and the 
University of Melbourne, compared with an insertion angle of 450° for the Nucleus Contour 
Advance.  
The Nucleus Hybrid L24 is the same device described in IDE No. G070191. See 
ATTACHMENT 1 for a letter from the Sponsor of IDE No. G070191 authorizing the FDA to 
review the information in IDE No. G070191 for purposes of the current IDE application.  The 
Nucleus Hybrid L24 electrode array also incorporates a platinum ring immediately proximal 
to the collar. The ring is positioned such that it is located at the site of entry after insertion of 
the array into the cochlea. The platinum ring is intended to encourage tissue growth to 
promote sealing of the entry into the cochlea after insertion, and to fixate the array, at the 
site of entry, so that it does not migrate into or out of the cochlea once inserted. 
Nucleus Hybrid S12 cochlear implant 
The Nucleus Hybrid S12 cochlear implant system comprises: 
• 
Nucleus Hybrid S12 cochlear implant, 
• 
Nucleus Freedom™ for Hybrid sound processor or Nucleus Hybrid SP, and 
• 
Nucleus Custom Sound™ programming software. 
The Nucleus Hybrid S12 cochlear implant incorporates an electrode array designed to 
stimulate the high-frequency, basal region of the cochlea while maintaining useful acoustic 
hearing in the low-frequency, apical region. This has been accomplished by employing a 
short, thin, straight intracochlear electrode array attached to a Nucleus cochlear implant 
receiver/stimulator (as used with the current, approved Nucleus Freedom cochlear implant). 
The electrode array incorporates a collar to prevent over-insertion, or further migration, into 
the cochlea beyond the point where the basal turn curves into the ascending segment. 
Thus, the electrode array is placed within the straight segment of the basal turn of the scala 
tympani via a cochleostomy. 

Iowa Cochlear Implant Clinical Research Center Hybrid Cochlear Implants in Severe to Profound Adults, 
Children, and Adolescents 
 
 
9/2011 Protocol approved by FDA (modification) 
181
The Nucleus Hybrid S12 is the same device described in IDE No. G070016. See 
ATTACHMENT 1 for a letter from the Sponsor of IDE No. G070016 authorizing the FDA to 
review the information in IDE No. G070016 for purposes of the current IDE application.  The 
Nucleus Hybrid S12 electrode array also incorporates a platinum ring immediately proximal 
to the collar. The ring is positioned such that it is located at the site of the cochleostomy 
after insertion of the array into the cochlea. The platinum ring is intended to encourage 
tissue growth to promote sealing of the cochleostomy after insertion, and to fixate the array, 
at the cochleostomy, so that it does not migrate into or out the cochlea once inserted. The 
Nucleus Hybrid S12 incorporates a 10-electrode array spread over 5.9 mm with an 
anticipated insertion depth of 10 mm. The resultant insertion angle is about 195-210° in the 
scala tympani for the Hybrid S12, compared with an insertion angle of 450° for the Nucleus 
Contour Advance. 
Nucleus Freedom for Hybrid sound processor  
The Nucleus Freedom for Hybrid sound processor (SP) is a behind-the-ear (BTE) sound 
processor developed to provide acoustic and electrical stimulation to hearing-impaired 
candidates with some low-frequency residual hearing. The Nucleus Freedom for Hybrid 
sound processor is compatible with the Nucleus Hybrid S12 implant and the Nucleus Hybrid 
L24 implant, as well as Nucleus 24 and Nucleus Freedom implants with Contour Advance or 
Straight electrode arrays. See ATTACHMENT 1 for a letter from the Sponsor of IDE No. 
G070016 and IDE No. G070191 authorizing the FDA to review the information in IDE No. 
G070016 and IDE No. G070191 for purposes of the current IDE application.  The Nucleus 
Freedom for Hybrid SP is functionally the same as the commercially approved Nucleus 
Freedom SP (P970051/S028), except that it can be programmed to allow acoustic 
stimulation. Acoustic stimulation is delivered via an acoustic module, called the Hybrid 
Receiver-In-The-Ear (RITE). The RITE connects to the sound processor via a cable molded 
into the earhook of the speech processor, thereby delivering acoustic amplification in a 
similar way to a conventional hearing aid.  
Custom Sound software  
Programming of the sound processor is achieved via Custom Sound™ software. Updates to 
the software with minor modifications may occur over the study period. Custom Sound 
permits the characterization of both electric and acoustic parameters required for Nucleus 
Hybrid L24 and S12 programming. The general approach for the electric programming is the 
same as for traditional cochlear implant recipients except that the software provides more 
flexible frequency boundary assignments for the 10 or 22 channels of the Nucleus Hybrid 
cochlear implants. The software provides the ability to specify the cut-off frequency at which 
acoustic stimulation ends and electric stimulation begins. In addition, the software provides 
a user interface for the clinician to program amplification characteristics such as gain and 
maximum output, frequency by frequency.  
2.3 
Preoperative Procedures 
2.3.1 Informed Consent 
A pre-operative interview will be conducted by the surgeon and audiologist to inform the 
potential candidate or parent(s) or legal guardian(s) of the child about all aspects of 
implantation with the Nucleus Hybrid L24 and S12 cochlear implants, study expectations, 
number of visits, surgical procedure, as well as the postoperative evaluation schedule.  The 
risks of surgery shall be explained to the candidate or to the parent(s) or guardian(s) as 
outlined on the Informed Consent and Assent Forms (ATTACHMENT 5A [Adults], 5B 
[Children and Adolescents], 5C [Assent]).  These include the normal risks associated with 
general anesthetic, as well as other risks such as facial paralysis, dizziness, meningitis, 
post-operative discomfort, and skin flap complications.  The potential limitations and 

Iowa Cochlear Implant Clinical Research Center Hybrid Cochlear Implants in Severe to Profound Adults, 
Children, and Adolescents 
 
 
9/2011 Protocol approved by FDA (modification) 
182
advantages of implantation with the Nucleus Hybrid L24 or Nucleus Hybrid S12 cochlear 
implants (e.g. loss of residual hearing) shall also be explained.  The potential candidate or 
parent(s) or legal guardian(s) of the child will be given adequate time to review the Informed 
Consent Form and given the opportunity to ask questions about the document itself and/or 
the study prior to signing the Informed Consent and Assent Forms.  The candidate or 
parent(s) or legal guardian(s) of the child will then be given a copy of the signed Informed 
Consent and Assent Forms. 
Note that the Informed Consent and Assent Forms must be reviewed and signed by the 
relevant parties prior to any study evaluation taking place.  Any testing, for screening 
purposes, completed prior to consent being obtained must be repeated after the participant 
consents to participation in the study. 
2.3.2 Hearing History 
Information regarding participant’s hearing-history (etiology, onset of hearing loss, duration 
of severe-to-profound hearing loss, amplification use) is to be reported. 
2.3.3 Medical/Surgical History 
The participant’s medical/surgical history is to be reported and is required in order to 
determine that the participant is medically suitable for cochlear implantation.  Information to 
be collected may include: the participant’s general medical history, medications, radiological 
information (i.e. x-rays), otologic history, and otologic surgical history. 
2.3.4 Fitting of Hearing Aids 
To be considered for the study, subjects will be assessed using appropriately fitted behind-
the-ear (BTE) or in-the-ear (ITE) hearing aids in each ear. There may be some individuals 
with very good low-frequency hearing who may prefer and perform comparably with no 
amplification in one or both ears. For the purposes of this study, subjects will use either their 
own hearing aids or be fitted with new/replacement aids for candidacy assessment. The 
decision to replace hearing aids will be based on real-ear measurements.  Specifically, the 
slope of the frequency response of the hearing aid must be within the target specified by the 
Audioscan Verifit System. If this can not be accomplished with the subject’s hearing aids, 
replacement hearing aids will be used. All speech perception inclusion criteria must be met 
with the subjects using hearing aids, even if amplification provides no additional benefit over 
natural acoustic hearing. 
If the subject does not use hearing aids on a daily basis, does not own hearing aids, or uses 
hearing aids that are not appropriately fitted, loaner hearing aids are to be fit and provided 
by the center. The subject will undergo a minimum 30-day hearing aid trial prior to being 
further assessed for study candidacy. Subjects must use the hearing aids on a full-time 
basis (8 hours per day). At the end of the trial period, aided word recognition will be 
reassessed to ensure that candidacy criteria are met. 
The National Acoustics Laboratories’ NAL/NL1 hearing aid fitting strategy will be used 
(Byrne, Parkinson, & Newall, 1990; Dillon, 1999) to assess the degree to which real-ear 
targets are met for Population 1 (adult subjects). Desired Sensation Level (DSL) method will 
be used to assess the degree to which real-ear targets are met for Population 2 (children 
and adolescents). These are the standard hearing aid fitting strategies used for these 
populations in most hearing aid centers. These prescriptive hearing aid fitting methods will 
use real-ear measures to verify that the slope of the frequency response is within target. 
During the fitting process, optimization of the response slope will be the priority for those 
frequencies where thresholds correspond to useful (or aidable) hearing. Studies (Ching, 
Dillon, & Byrne, 1998; Hogan & Turner, 1998; Turner & Brus, 2001) have suggested that 
hearing may be no longer useful for thresholds beyond 55 to 80 dB HL, at least for higher 

Iowa Cochlear Implant Clinical Research Center Hybrid Cochlear Implants in Severe to Profound Adults, 
Children, and Adolescents 
 
 
9/2011 Protocol approved by FDA (modification) 
183
frequencies. According to Turner (2006), provision of amplification for lower frequencies 
does not appear to be constrained to the same extent by thresholds for lower frequencies (< 
2500 Hz), though no proposal is made as to when such a constraint might occur.  
Taking a conservative approach, useful hearing will be defined by hearing thresholds better 
than 90 dB HL for this study. Hearing levels 90 dB HL or poorer are considered to not be 
aidable, from an amplification perspective.  
It is recognized that prescriptive methods are based on average requirements, and that 
individuals may find deviations from target values optimal for sound loudness, quality, or 
clarity. For example, individual adjustments required to relieve occlusion effects will be 
permitted. 
2.3.5 Audiological Assessment 
The degree of hearing loss will be determined by standard audiometric technique. 
Audiological assessment will include unaided and aided audiometric thresholds. 
Unaided audiometric thresholds will be obtained for each ear, with insert earphones, when 
possible, using the standard audiometric technique for pure-tone air-conduction testing.  
Aided audiometric thresholds will be obtained for each ear in the sound-field using 
frequency-modulated (FM) noise and using the standard audiometric technique with the 
speakers positioned at 0° azimuth relative to the subject’s head. As these subjects may 
have some low-frequency hearing bilaterally it is important that appropriate consideration be 
made for masking/plugging the contralateral ear during aided testing when a unilateral ear is 
being tested. Testing, for both ears, will include the following: 
• 
Unaided Air Conduction thresholds at 125, 250, 500, 750, 1000, 1500, 2000, 3000, 
4000, 6000, and 8000 Hz; 
• 
Bone conduction thresholds at 125, 250, 500, 750, 1000, 1500, 2000, and 4000 Hz; 
• 
Aided Air Conduction thresholds at 125, 250, 500, 750, 1000, 1500, 2000, 3000, and 
4000 Hz; 
• 
Tympanometry in each ear. 
The CNC word recognition test in quiet (at 60 dB A) will be administered in aided conditions 
(right hearing aid alone and left hearing aid alone) to adults to determine if a candidate 
meets the speech perception criteria1. Candidates must demonstrate a lack of word 
understanding, defined as preoperative aided CNC word recognition test recognition scores 
between 0% and 35% inclusive in the ear to be implanted and ≤ 60% in the contralateral 
ear. The non-test ear will be plugged for all test conditions. 
The PB-K word recognition test in quiet (at 60 dB A) will be administered in aided conditions 
(right hearing aid alone and left hearing aid alone) to adults determine if a candidate meets 
the speech perception criteria2. Candidates must demonstrate a lack of word understanding, 
defined as preoperative aided PB-K word recognition test recognition scores between 0% 
and 50% inclusive in the ear to be implanted and ≤ 60% in the contralateral ear. The non-
test ear will be plugged for all test conditions. 
 
1 For unilateral test conditions, the ear contralateral to the test ear will need to be occluded with 
sound-attenuated ear plugs for aided speech perception testing. 
2 For unilateral test conditions, the ear contralateral to the test ear will need to be occluded with 
sound-attenuated ear plugs for aided speech perception testing. 

Iowa Cochlear Implant Clinical Research Center Hybrid Cochlear Implants in Severe to Profound Adults, 
Children, and Adolescents 
 
 
9/2011 Protocol approved by FDA (modification) 
184
A candidate is only considered enrolled when 1) a properly executed informed consent and 
assent form has been completed and returned, 2) his/her pre-operative candidacy 
evaluation is accepted, and 3) both forms have been reviewed and approved by the 
University of Iowa. 
2.3.6 Baseline Testing: Population 1 (Adults) 
Once candidacy has been determined, auditory function will be evaluated in order to 
establish a baseline level on those that meet criteria. The tests will be administered using 
the same bilateral hearing aids used to determine candidacy.  The following battery of 
measures will be administered: 
2.3.6.1  Speech Perception Testing 
1.         Consonant-Nucleus-Consonant monosyllabic words (CNC, Tillman & Carhart, 1966) 
in quiet.  Two lists of CNC words will be administered in each test condition. Testing will be 
attempted in the ear to be implanted and bilaterally at 60 dBA. 
2.        The AzBio sentence (Spahr & Dorman, 2005) lists were created from a corpus of 
1000 sentences recorded by 4 untrained speakers, 2 male and 2 female.  The original 
recordings from each speaker were normalized to be approximately equal in level (dB RMS).  
The materials were processed using a 5-channel cochlear implant simulation and presented 
to 15 normal-hearing listeners to determine the average level of intelligibility for each 
sentence.  The results allowed for the creation of 33 lists of 20 sentences.  Each list includes 
5 sentences from each of the 4 speakers and the average level of intelligibility of each list is 
85% +/- 1%. Two lists of the AzBio sentences will be presented at a target presentation level 
of 60 dBA with a +5 dB signal-to-noise ratio or SNR (i.e., the competitor will be set to 55 
dBA). For baseline testing, the target and competitor will be presented from the same 
speaker at 0° azimuth using appropriately fit hearing aids unilaterally for the ear to be 
implanted and bilaterally. 
3.        A Speech Reception Threshold (SRT) (Turner et al., 2004) is a 12-item forced-choice 
test in which the patient listens for one of 12 target spondees spoken by a female (birthday, 
drawbridge, eardrum, iceberg, mousetrap, northwest, padlock, playground, sidewalk, 
stairway, toothbrush, and woodwork). The target stimulus is delivered under the control of 
custom software in the presence of either speech (i.e., two competing talkers, one male, and 
one female) or broad band noise. The speech consists of each competing talker repeating 
the same sentence (each talker a different sentence) for each stimulus presentation. The 
level of the competing signal is adaptively varied depending on the subject’s response. That 
is, the level increases (i.e., producing a more aversive signal-to-noise ratio) when a correct 
response is made and decreased (i.e., producing a less aversive signal-to-noise ratio) when 
an incorrect response is made. For this study the target stimulus will presented from a 
loudspeaker located at 0° azimuth at 60 dBA. The competing signal will be directed towards 
the right ear (90° azimuth) or towards the left ear (270° azimuth). The initial presentation 
level of the competing signal is more arbitrarily set, but generally at, or close to, the same 
level as the target level. The level of the competitor is then varied adaptively up or down 
depending on the subject’s response. The level initially varies in 8 dB steps, progressing to 
4 dB and finally 2 dB steps. A threshold is established once 14 reversals are obtained. 
Threshold is calculated as the average of the levels at which each of the last 10 reversals 
occurred. The competing signal is directed towards a different channel on the audiometer 
such that the competitor could be presented from either the same location as the target 
speech signal or from a loudspeaker located elsewhere. A lower signal-to-noise ratio (SNR) 
to achieve 50% recognition indicated improvement. In other words, equivalent speech 
understanding is maintained at a more aversive SNR. Testing will be attempted using 
appropriately fit hearing aids contralaterally to the ear to be implanted and bilaterally. 

Iowa Cochlear Implant Clinical Research Center Hybrid Cochlear Implants in Severe to Profound Adults, 
Children, and Adolescents 
 
 
9/2011 Protocol approved by FDA (modification) 
185
Care must be taken to plug the contralateral ear, or provide contralateral masking, when a 
hearing aid is removed for a test condition (e.g. unilateral testing). 
2.3.6.2  Localization Testing  
1.        A multiple loudspeaker Everyday Sounds Localization Test (Dunn, Tyler, & Witt, 
2005) using 16 different sound items will be administered. Localization performance will be 
determined by calculating the Average Root Mean Square (RMS)-error in degrees. Testing 
will be attempted bilaterally using appropriately fit hearing aids at 60 dBA. 
2.3.6.3  Music Perception 
1.        Real World Melody Recognition (CMR-R; Gfeller, Olszewski, Turner, Gantz, Oleson, 
2006). This test examines the influence of speech and pitch perception in the recognition of 
excerpts from “real-world” melodies. Testing will be attempted using appropriately fit hearing 
aids in the ear to be implanted at 70 dBA. 
2.        Modified Melodies Test: Nudge 2 (MMT; Swanson, Dawson, McDermott, 2009). This 
test assesses the ability of participants to detect pitch errors in two familiar melodies: Old 
MacDonald and Twinkle Twinkle when specific notes are modified/nudged by 2 semitones. 
Testing will be attempted using appropriately fit hearing aids in the ear to be implanted at 70 
dBA. 
3.        Complex-Tone Pitch Discrimination (CTPD, Gfeller, Turner, Woodworth, Mehr, Fearn, 
Witt, Stordahl, 2002). This test assesses the participants’ ability to discriminate direction of 
pitch change as a function of interval size (fundamental frequency range, 131-1048 Hz). 
This adaptive test results in a threshold (across all frequencies) at which the participant is 
able to achieve 75% accuracy. This is a brief test (5-10 minutes) that can be repeatedly 
administered in multiple conditions accurately. Testing will be attempted using appropriately 
fit hearing aids in the ear to be implanted at 70 dBA. 
4.        Iowa Test Appraisal of Sound Quality (ITASQ, Gfeller, Witt, Woodworth, Mehr, and 
Knutson, 2002). This test evaluates participants’ appraisal of timbre and sound quality of 
music instruments and real-world music with and without lyrics. Using 4 bipolar adjective 
scales, participants describe the sound quality of the each excerpt and also rank their 
preference for the sound. Testing will be attempted using appropriately fit hearing aids in the 
best aided condition at 70 dBA. 
2.3.7 Baseline Testing: Population 2 (Children and Adolescents) 
2.3.7.1  Speech Perception Testing 
1. 
Phonetically Balanced-Kindergarten (PB-K, Haskins, 1949) word test in quiet. The 
PB-K test has multiple 50 word lists.  The test will be scored as total number of words 
correct as well as phonemically. Testing will be attempted using appropriately fit hearing 
aids in the ear to be implanted and bilaterally at 60 dBA. This will be administered to 
children between the ages of 5-6 years.  
2. 
Consonant-Nucleus-Consonant monosyllabic words (CNC, Tillman & Carhart, 1966) 
in quiet.  Two lists of CNC words will be administered in each test condition. Testing will be 
attempted in the ear to be implanted and bilaterally at 60 dBA. This will be administered to 
children between the ages of 7-15 years. 
3. 
Computer-assisted Speech Perception Assessment Test (CASPA, Boothroyd, 2004; 
Mackersie, Boothroyd, & Minniear, 2001) in noise using 20 sets of 10 CVC words. Testing 
will be administered to children and adolescents between the ages of 7-15 years at 65 dBA 
speech level with a +10 signal to noise ratio.  Testing will be attempted in the ear to be 

Iowa Cochlear Implant Clinical Research Center Hybrid Cochlear Implants in Severe to Profound Adults, 
Children, and Adolescents 
 
 
9/2011 Protocol approved by FDA (modification) 
186
implanted and bilaterally. Results will be scored in terms of percent correct whole word and 
percent correct phonemes.  
Care must be taken to plug the contralateral or ipsilateral ear, or provide contralateral 
masking when testing individual ears. 
2.3.7.2  Localization Testing 
1. 
A multiple loudspeaker Everyday Sounds Localization Test (Dunn, Tyler, & Witt, 
2005) using 16 different sound items will be administered. Localization performance will be 
determined by calculating the Average Root Mean Square (RMS)-error in degrees. Testing 
will be attempted bilaterally using appropriately fit hearing aids at 60 dBA to children 
between the ages of 7-15 years. 
2.3.7.3  Speech Language Testing 
1. 
Peabody Picture Vocabulary Development Scale (PPVT, Dunn & Dunn, 1997).  The 
PPVT is a standardized, norm-referenced measure of receptive vocabulary skills. The test is 
a multiple-choice measure consisting of sets of four black and white line drawings.  The 
examiner names one of the pictures and the test recipient is expected to indicate which 
picture has been labeled, either verbally or through pointing.  It is appropriate for children 
and adults from 2 years, 6 months to 90 years, 11 months of age. Testing will be attempted 
bilaterally.  
2. 
Goldman Fristo Test of Articulation (GFTA, Goldman & Fristoe, 2000).  The GFTA-2 
is a standardized, norm-based articulation measure that samples spontaneous sound 
production.  Children are asked to respond to picture plates and verbal cues from the 
examiner with single words that test consonant accuracy in initial, medial, and final 
positions. This measure has norms based on the performance of normal-hearing children 
from age 2 years to 21 years. Testing will be attempted bilaterally.  
3. 
Woodcock Reading Mastery Test (WRMT-R/NU, Woodcock, 1998). These tests are 
standardized from kindergarten through high school. The Word Identification and Word 
Attack subtests from the WRMT-R will be used to assess children’s word recognition 
abilities. These subtests measure accuracy of sight word recognition and phonetic decoding 
of pronounceable non-words. Reading comprehension abilities will be assessed by the 
Passage Comprehension subtest of the WRMT-R. The WRMT-R uses a cloze procedure in 
which the participants are asked to read a short passage and orally provide a missing word. 
It is appropriate for children and adults from 5 years, 0 months to 20 years, 0 months of age. 
Testing will be attempted bilaterally.  
4. 
Comprehensive Assessment of Spoken Language (CASL, Carrow- Wolfolk, 1999) 
Carrow-Woolfolk, 1999) is a standardized, norm-referenced measure of oral language 
skills.  It is appropriate for children ages 3 to 21 years of age.  The test is composed of core 
battery of measures which represents different aspects of language categories (semantics, 
syntax, and pragmatics). Testing will be attempted bilaterally.  
2.3.7.4  Music Perception 
1. 
Complex-Tone Pitch Discrimination (CTPD, Gfeller, Turner, Woodworth, Mehr, Fearn, 
Witt, Stordahl, 2002) assesses the participants’ ability to discriminate direction of pitch 
change as a function of interval size (fundamental frequency range, 131-1048 Hz). This 
adaptive test results in a threshold (across all frequencies) at which the participant is able to 
achieve 75% accuracy. This is a brief test (5-10 minutes) that can be repeatedly 
administered in multiple conditions accurately. It is administered in the best aided condition 
in the ear to be implanted at 70 dBA. 

Iowa Cochlear Implant Clinical Research Center Hybrid Cochlear Implants in Severe to Profound Adults, 
Children, and Adolescents 
 
 
9/2011 Protocol approved by FDA (modification) 
187
2. 
Melody Recognition by Information Level (MRIL, Olszewski, Gfeller, Froman, 
Stordahl, Tomblin, 2005) assesses the participants’ ability to recognize and identify simple 
melodies in closed set provided in 4 different formats: sung with video, sung without video, 
melody with rhythm, and isochronous (melody without rhythm) in random order. Previous 
research with children and adults who use CIs has shown that while adults with traditional 
long-electrode cochlear implants are able to perform successfully in three of the four formats 
(performing poorly on the isochronous condition), adults with short-electrode cochlear 
implants are able to perform successfully on all formats. Conversely, children with long-
electrode devices are only able to perform well on those that include lyrics and perform at or 
below change on the other two conditions. It is administered in the best aided condition in 
the ear to be implanted at 70 dBA. 
2.3.7.5 Calibration 
Speech perception, music perception, and localization tests will be calibrated using a 
calibration tone (or calibration sound file). A sound-level meter will be used to measure the 
dBA level of the calibration tone at a distance of 1 meter from the loudspeaker.  The 
loudness will be adjusted through the audiometer or receiver to achieve the desired 
loudness level for the specific test. 
2.3.8 Surgical Procedure 
The surgical procedure for the Nucleus Hybrid L24 and Hybrid S12 cochlear implant 
requires care to prevent inner ear damage.  These procedures are the same as described in 
IDE No. G070191 and G070016. See ATTACHMENT 1 for a letter from the Sponsor of IDE 
No. G070191 and G070016 authorizing the FDA to review the information in IDE No. 
G070191 and G070016 for purposes of the current IDE application.   
The most important tenets are given below. 
1.  A complete mastoidectomy with preservation of the cortex in the area of the tegmen 
mastoideum performed. Completion of exposure, bony work, and soft tissue work before 
completing the cochleostomy. This includes drilling a seat for the electronic package, 
harvesting and constructing a temporal fascia washer. The facial recess or posterior 
tympanotomy must be opened to allow complete visualization of the round window. The 
overhanging niche of the round window must be removed using a diamond burr completely 
exposing the entire round window membrane. These steps minimize the open cochlea’s 
exposure to blood and bone dust.  A suture is placed through the boney over hang at the 
tegmen mastoideum to secure the electrode lead prior to placing the electrode in the scala 
tympani.  This suture stabilizes the springy lead of the implant and prevents translational 
movement in the scala tympani as the electrode is advanced. 
2.  Minimally traumatic cochleostomy. A strategy similar to that used to perform a ‘drill-out’ 
stapedectomy.  This includes making sure bleeding is controlled, bone is slowly removed 
over the area of the cochleostomy leaving the endosteum of the inner ear intact, and not 
using suction in the area of an open inner ear.  The cochleostomy must be placed 
approximately 1 mm anterior and inferior to the floor attachment of the round window 
membrane. The promontory of the cochlea in this portion can be more than 1 mm thick. It is 
suggested that the promontory be saucerized in this region with a 1-mm diamond burr. 
Placement of the cochleostomy in the anterior-inferior position to the round window 
membrane avoids damage to the scala media and spiral ligament. The burr should not enter 
the scala tympani. The endosteum is opened with a 0.2-mm footplate hook. The smallest 
cochleostomy needed to insert the implant is made (0.7–0.8 mm). No suctioning of the 
perilymph is permitted.   
3.  Minimally traumatic insertion. Short lapse of time between opening the cochlea and 
insertion is emphasized.  The electrode is stabilized with a suture at the lateral tegmen 

Iowa Cochlear Implant Clinical Research Center Hybrid Cochlear Implants in Severe to Profound Adults, 
Children, and Adolescents 
 
 
9/2011 Protocol approved by FDA (modification) 
188
mastoid cortex prior to insertion into the cochlea. Actual insertion of the electrode is slow 
(30–45 s) to minimize intracochlear trauma.  The fascia washer seals the cochleostomy.  No 
further packing in the scala tympani is allowed. 
2.4 
 Postoperative Procedures 
2.4.1 Device Activation  
One day prior to activation, subjects without a contraindication to glucocorticoid therapy will 
be started on prednisone 1mg/kg for 1 week. Subjects will be asked to undergo weekly 
audiometric testing for one month to monitor acoustic hearing.  If drops in threshold of 15 dB 
HL or more at 125, 250, or 500 are observed, additional prednisone 1mg/kg will be 
prescribed for 14 days with a gradual taper off over the following week. 
Electric Fitting: 
The participants will be fit with Nucleus Freedom for Hybrid sound processor (or most 
current combined speech processor) speech processor using a behind-the-ear (BTE) 
controller or body level controller. Speech processing strategies used with this device will 
include ACE (RE), ACE, CIS (RE), CIS or SPEAK, which are all FDA approved for adults.  
Threshold (T) and comfort (C) values will be measured for the electrical stimulation for each 
of the channels (22 on the Nucleus Hybrid L24 cochlear implant and 10 on the Nucleus 
Hybrid S12 cochlear implant).  Impedance telemetry results using common ground (CG) and 
monopolar (MP1, MP2 and MP1+2) stimulation modes will also be recorded.  This 
information will be used to program the speech processor and also to monitor the device for 
possible degradation of function and/or damage to neural elements. 
The process of adjusting the speech processor programs might take place over a period of 
several months for younger children.  Play audiometry or standard audiometric techniques 
will be used, as appropriate for the child’s developmental level, to determine electrical 
threshold levels for the channels in a child’s program.   
Subjects will receive extensive counseling regarding how the equipment functions, 
maintenance and troubleshooting of the device. 
Acoustic Fitting: 
The acoustic component of the Hybrid sound processor will be appropriately fit using the 
NAL-NL1 for adults and DSL for children and adolescents (as used preoperatively for the 
acoustic hearing aids) to assess the degree to which real-ear targets are met for each 
subject.  Fitting methodology with the acoustic component of the Hybrid sound processor is 
unchanged from that of conventional acoustic hearing aids. 
The basic programming approach will be to assign frequency channels to the Hybrid 
electrode array that supplement the acoustic sensitivity. In other words, the frequency 
assignment of the electrical stimulation will begin at the frequency where acoustic hearing is 
no longer useful. For this purpose, hearing thresholds greater than 90 dB HL will be 
considered not useful from an amplification perspective and not aidable acoustically. For 
example, if the subject’s hearing in the implanted ear is more than 90 dB HL for frequencies 
at and above 1000 Hz (i.e., useful acoustic hearing up to 750 Hz), the lower frequency 
boundary for electric stimulation will be set as close as possible to 750 Hz (i.e., the last 
aidable frequency). That is, electrical stimulation will be provided for inputs from around 750 
to 8000 Hz and acoustic for frequencies at and below 750 Hz. Thus, there will be minimal 
overlap between the acoustic and the electric signals.  

Iowa Cochlear Implant Clinical Research Center Hybrid Cochlear Implants in Severe to Profound Adults, 
Children, and Adolescents 
 
 
9/2011 Protocol approved by FDA (modification) 
189
2.4.2 Programming Follow-up 
Following surgical implantation of the device and an adequate healing period, the implants 
will be activated (usually 4 to 6 weeks after surgery) and programmed. However, prior to the 
4-month post-operative evaluation, additional programming follow-up sessions will be 
scheduled at 2 weeks and 1 month as it is not unusual for threshold and comfort levels to 
change during the initial postactivation period. The follow-up sessions will allow the 
participant’s T- and C-levels to be checked as well as any programming adjustments to be 
made based on the participant’s initial experience with the device. Electrical impedance 
measures also will be obtained. Additional programming at additional post-activation 
intervals will be assessed and conducted as needed.  
 
C-levels will never be set above 200CL on any electrode. If stimulation at 200CL with the 
default pulse width of 25us does not elicit a maximal loudness percept, the audiologist will 
widen the pulse width on that channel and resume psychophysical measurements 
approximately 5CL below an approximately equal charge level. This will entail manually 
reducing the current level in the following manner: 
 
 
 
When pulse duration 
is increased from: 
The audiologist will manually decrease 
the CL from 200CL to: 
25us to 37us 
170CL 
25us to 50us 
155CL 
37us to 50us 
175CL 
50us to 75us 
170CL 
Parents and professionals working with the children who participate in this study will receive 
extensive counseling regarding how the equipment functions, maintenance and 
troubleshooting of the device, and progression of auditory skills of children who cochlear 
implants.  This is accomplished during visits to the center and through in-service training 
offered locally via the fiberoptic teleconferences. 
2.4.3 Audiologic Follow-up 
Audiological Testing: 
Unaided audiometric thresholds will be obtained for each ear, with insert earphones 
whenever possible, using the standard audiometric technique for pure-tone air-conduction 
testing.  During the first month after activation of the Hybrid implant, subjects will be seen on 
a weekly basis to measure residual acoustic hearing.  If more than a 10 dB downward 
threshold shift is identified, oral prednisone 1mg/kg once a day for 7 days will be prescribed. 
If hearing is regained or continues to fluctuate, the treating physician and the patient would 
discuss another trial with the prednisone. If after use of the prednisone there is no change in 
hearing, the prednisone will be stopped. Additional audiologic follow-up will occur at 
intervals of 3, 6, 12, and 24 months in adults and at intervals of 4, 8, 12, 18, 24 months, and 
annually thereafter for three years in children and adolescents. 
Unaided (and aided if necessary) testing, for both ears, will include the following: 
• 
Unaided Air Conduction thresholds at 125, 250, 500, 750, 1000, 1500, 2000, 3000, 
4000, 6000, and 8000 Hz; 
• 
Bone conduction thresholds at 125, 250, 500, 750, 1000, 1500, 2000, and 4000 Hz; 

Iowa Cochlear Implant Clinical Research Center Hybrid Cochlear Implants in Severe to Profound Adults, 
Children, and Adolescents 
 
 
9/2011 Protocol approved by FDA (modification) 
190
• 
Aided Air Conduction thresholds at 125, 250, 500, 750, 1000, 1500, 2000, 3000, and 
4000 Hz; 
Hearing Aid Verification: 
A hearing aid check will be completed by the clinician to verify that the contralateral hearing 
aid and the acoustic component of the Hybrid sound processor for the implanted ear, if 
used, are functional prior to aided testing. If any significant change in unaided thresholds is 
noted then the amplification fitting(s) should be re-evaluated and adjustments made if 
necessary. A significant change for this purpose only is defined as a shift of more than 10 
dB (for the better or worse) at two or more (i.e., < 90 dB HL) frequencies. Hearing aid 
verification will occur at intervals of 3, 6, 12, and 24 months in adults and at intervals of 4, 8, 
12, 18, 24 months and annually thereafter for three years in children and adolescents. 
2.4.4 Post-operative Testing: Population 1 (Adults) 
Testing will be assessed longitudinally 3, 6, 12, and 24 months.  Descriptions of tests are 
provided in the baseline testing section. 
2.4.4.1 Speech Perception Testing 
Tests will be attempted in the following conditions (unless otherwise noted): 
 
Electric stimulation alone (Implant only), 
 
Hybrid stimulation (i.e., Implant + Ipsilateral Hearing Aid), 
 
Bimodal stimulation (i.e. Implant and Contralateral Hearing Aid) 
 
Combined stimulation (i.e., Implant + Ipsilateral and Contralateral Hearing 
Aids). 
1. 
The CNC Word recognition test (two lists per condition, at 60 dBA). 
2. 
The AzBio sentence lists.  Two lists of the AzBio sentences will be presented at a 
target presentation level of 60 dBA with a +5 dB signal-to-noise ratio or SNR (i.e., the 
competitor will be set to 55 dBA).  
3. 
A Speech Reception Threshold (SRT) test. Tested only at 6 months and 24 months 
post-operatively in the Combined and Bimodal Conditions.   
Care must be taken to plug the contralateral ear, or provide contralateral masking, when a 
hearing aid is removed for a test condition (e.g. electric stimulation alone). 
2.4.4.2  Localization Testing 
1. 
Everyday Sounds Localization test attempted in the combined and bimodal 
conditions at 60 dBA (tested only at 6 months and 24 months post-operatively). 
2.4.4.3 Music Perception 
1.        Real World Melody Recognition (CMR-R). This test is administered in the hybrid 
condition only at 70 dBA to reduce the possibility of a learning effect from repeated 
exposure in the same test session. 
2.       Modified Melodies Test: Nudge 2 (MMT). This test is administered in the hybrid and 
CI-only condition at 70 dBA. 
3.       Complex-Tone Pitch Discrimination (CTPD). This is a brief test (5-10 minutes) that 
can be repeatedly administered in multiple conditions accurately. This test is administered in 
the hybrid and CI-only condition at 70 dBA. 

Iowa Cochlear Implant Clinical Research Center Hybrid Cochlear Implants in Severe to Profound Adults, 
Children, and Adolescents 
 
 
9/2011 Protocol approved by FDA (modification) 
191
4.       Iowa Test Appraisal of Sound Quality (ITASQ). This test is administered in the 
combined condition only at 70 dBA to reflect responses associated with the subject’s 
everyday listening condition. 
2.4.5 Post-operative Testing: Population 2 (Children and Adolescents) 
Testing will be assessed longitudinally at 4, 8, 12, 18, 24 months and annually thereafter for 
three years in children and adolescents. 
Descriptions of tests are provided in the baseline testing section. 
2.4.5.1 Speech Perception Testing  
Tests will be attempted in the following conditions (unless otherwise noted): 
 
Electric stimulation alone, 
 
Hybrid stimulation (i.e., Implant + Ipsilateral Hearing Aid), 
 
Combined stimulation (i.e., Implant + Ipsilateral and Contralateral Hearing 
Aids). 
1. 
Phonetically Balanced-Kindergarten (PB-K) word test in quiet. Testing will be 
administered at 60 dBA to children between the ages of 5-6 years. 
2. 
Consonant-Nucleus-Consonant monosyllabic words (CNC) in quiet.  Two lists of 
CNC words will be administered in each test condition. Testing will be administered at 60 
dBA to children between the ages of 7-15 years. 
3. 
Computer-assisted Speech Perception Assessment Test (CASPA) in noise. Testing 
will be administered to children and adolescents between the ages of 7-15 years at 65 dBA 
speech level with a +10 signal to noise ratio.   
Care must be taken to plug the contralateral or ipsilateral ear, or provide contralateral 
masking when acoustic stimulation is not warranted (e.g. testing CI-Only or Hybrid 
conditions). 
2.4.5.2 Localization Testing 
1.   
Everyday Sounds Localization test attempted in the combined and bimodal 
conditions at 60 dBA (tested only at 12 months and 24 months post-operatively). 
2.4.5.3 Speech and Language Testing – all administered in the bilateral listening condition 
at 12 months and annually thereafter. 
All tests will be administered in the combined stimulation condition, unless otherwise noted. 
1. 
Peabody Picture Vocabulary Development Scale (PPVT)   
2. 
Goldman Fristoe Test of Articulation (GFTA)   
3. 
Woodcock Reading Mastery Test (WRMT-R/NU)  
4. 
Comprehensive Assessment of Spoken Language (CASL) 
2.4.5.4 Music Perception 
1. 
Complex-Tone Pitch Discrimination (CTPD). This is a brief test (5-10 minutes) that 
can be repeatedly administered in multiple conditions accurately. It is administered in the 
hybrid and CI-only condition at 70 dBA. 
2. 
Melody Recognition by Information Level (MRIL). This test is administered in the only 
hybrid condition at 70 dBA to reduce the possibility of a learning effect from repeated 
exposure in the same test session. 

Iowa Cochlear Implant Clinical Research Center Hybrid Cochlear Implants in Severe to Profound Adults, 
Children, and Adolescents 
 
 
9/2011 Protocol approved by FDA (modification) 
192
2.4.6 Psychophysical and Electrical Impedance Measurements: 
The following psychophysical and electrical impedance measurements will be attempted at 
3, 6, 12, and 24 months in adults and at 4, 8, 12, 18, 24 months and annually thereafter for 
three years in children and adolescents.   
1. Electrical thresholds measured in current level. 
2. Electrical maximum comfort levels measured in current level. 
3. Impedance telemetry results using common ground (CG) and monopolar (MP1, MP2, 
MP1+2) stimulation modes. 
2.5 
Adverse Effects 
Adverse effects are any undesirable clinical or medical occurrence associated with use of 
the device or participation in the study. Any adverse effects are to be reported to the FDA 
and our IRB via the “Adverse Effects Form”. The Primary Investigator will be required to 
verify that there are or there are no adverse effects to report. 
Adverse effects will be reported if observed, even if acknowledged as risk factors in the 
consent. Adverse effects include: 
1. Sudden changes in residual low-frequency hearing. Specifically, a PTA at 125, 250, 
500 HZ that is ≥30 dB HL. 
2. Total loss of residual hearing 
3. Vertigo, dizziness, or balance problems that did not exist preoperatively or worsened 
postoperatively 
4. Facial nerve problems 
5. Meningitis 
6. Perilymphatic fistulae 
7. Tinnitus that did not exist preoperatively or worsened postoperatively 
8. Implant Migration/Extrusion 
9. Skin flap problems 
10.  Device-related/programming problems 
11.  Infection requiring explantation 
12.  Device failure requiring explantation 
2.6 
Unanticipated Adverse Events 
Unanticipated adverse device effects refer to any event not identified above that represents 
a “serious adverse effect on health or safety or any life-threatening problem or death caused 
by, or associated with, a device if that effect, problem or death was not previously identified 
in nature, severity, or degree of incidence in the investigational plan or application, or any 
other unanticipated serious problem associated with a device that relates to the rights, 
safety, or welfare of subjects.” [FDA 21 CFR 812.3(s)] 
Investigators are to inform their respective Institutional Review Boards (IRBs) immediately if 
an unanticipated adverse device effect is suspected (no more than 10 working days after the 
investigator learns of the effect). If the case is determined to be an unanticipated adverse 
device effect, the investigator will fill out an “Unanticipated Adverse Device Effect Form.” 
University of Iowa will report the results of an evaluation of the unanticipated adverse device 
effect to the FDA and all other reviewing IRBs and investigators within 10 working days after 
first receiving notice of the event. 
2.7 
Data Analysis for Population 1 
In order to assess the feasibility of using the L24 electrode arrays in adults, data will be 
analyzed individually and with group statistics.  We will measure success of this study by 
assessing speech perception, localization, and music performance as described above in 
the test descriptions.  We will attempt to compare these results with adults implanted with 

Iowa Cochlear Implant Clinical Research Center Hybrid Cochlear Implants in Severe to Profound Adults, 
Children, and Adolescents 
 
 
9/2011 Protocol approved by FDA (modification) 
193
standard-length devices on one or both ears on the same test measures.  Efficacy of the 
Nucleus Hybrid L24 cochlear implant system will be determined by a comparison of 
preoperative (best aided) vs. postoperative outcomes measures. Efficacy will also be 
measure by statistically significant differences between mean, preoperative speech 
perception scores (best aided) and postoperative scores. The null hypothesis to be tested is 
that there is no difference for the subjects between their pre- vs. postoperative speech 
performance  
Because this is a feasibility study, we will only be implanting up to 15 adults with the 
Nucleus Hybrid L24 cochlear implant. We recognize that this small number of subjects may 
not afford us enough statistical power to adequately answer all questions associated with 
the feasibility of using a short electrode device for the provision of acoustic and electric 
sound processing to adults who demonstrate severe sensorineural hearing loss.  However, 
it may lend us foundational knowledge to assess whether the devices are beneficial to this 
population of adults.  
2.8 
Data Analysis for Population 2 
In order to assess the feasibility of using the Nucleus Hybrid S12 and L24 electrode arrays 
in children and adolescents, data will be analyzed individually and with group statistics.  We 
will measure success of this study by assessing speech perception, localization, 
speech/language development, and music performance as described above in the test 
descriptions.  We will attempt to compare these results with age-matched children implanted 
with standard-length devices on one or both ears on the same speech perception and 
speech/language measures.  Efficacy of the Nucleus Hybrid S12 and L24 cochlear implant 
systems will be determined by a comparison of preoperative (best aided) vs. postoperative 
outcomes measures. Efficacy will also be measure by statistically significant differences 
between mean, preoperative speech perception scores (best aided) and postoperative 
scores. The null hypothesis to be tested is that there is no difference for the subjects 
between their pre- vs. postoperative speech performance  
Because this is a feasibility study, we will only be implanting up to 15 children (5-12 years of 
age) or adolescents (13-15 years of age) with the Nucleus Hybrid S12 and 15 children (5-12 
years of age) or adolescents (13-15 years of age) with the Nucleus Hybrid L24 cochlear 
implants. We recognize that this small number of subjects may not afford us enough 
statistical power to adequately answer all questions associated with the feasibility of using a 
short electrode device for the provision of acoustic and electric sound processing to children 
who demonstrate severe sensorineural hearing loss.  However, it may lend us foundational 
knowledge to assess whether the devices are beneficial to this population of children. 
2.9 
Longer Electrode Array Reimplantation 
Some individuals have elected to have the Nucleus Hybrid cochlear implant removed and 
replaced with a standard, long electrode-array cochlear implant. This has typically been in 
cases where individuals have experienced a complete loss of residual hearing. It is a case-
by-case decision to replace the Hybrid L24 with a standard length implant.  The implant only 
data provided in the unpublished data section demonstrates that the performance is similar 
to a standard length implant.  If the subject is performing at the average performance level 
one would not necessarily benefit from a change in device.  
Additionally, the insertion of an electrode array may alter the perception of speech and other 
sounds compared to their sound quality prior to implantation, this may be due to the use of 
an electrode array, and/or changes in residual hearing. Subjects who elect to be implanted 
with a standard cochlear implant in the test ear, in place of the Nucleus Hybrid L24 or S12 
(whichever they are implanted with) cochlear implant, will be required to complete the study 
protocol as outlined above. 

Iowa Cochlear Implant Clinical Research Center Hybrid Cochlear Implants in Severe to Profound Adults, 
Children, and Adolescents 
 
 
9/2011 Protocol approved by FDA (modification) 
194
2.10 References 
Boothroyd, A (2004). Computer-Assisted Speech Perception Assessment. Accessed 
6/27/07 at http://www.arthurboothroyd.com/pages/849379/index.htm. 
Byrne, D, Parkinson, A, & Newall, P (1990). Hearing aid gain and frequency response 
requirements for the severely/profoundly hearing-impaired. Ear and Hearing, 11, 
40-49. 
Carrow-Woolfolk, E (1999).  Comprehensive assessment of spoken 
language.  Minneapolis, MN:  NCS Pearson, Inc. 
Ching, T, Dillon, H, & Byrne, D (1998). Speech recognition of hearing-impaired listeners: 
predictions from audibility and the limited role of high-frequency amplification. 
Journal of Acoustic Society of America, 103, 1128-1140 
Dillon, H (1999). NAL-NL1: A new prescriptive fitting procedure for non-linear hearing 
aids. Hearing Journal, 52, 10-16. 
Dunn, CC, Tyler, RS, & Witt, SA (2005). Benefit of wearing a hearing aid on the 
unimplanted ear in adult users of a cochlear implant. Journal of Speech, 
Language, and Hearing Research, 48, (3), 668-680. 
Dunn, LM, & Dunn, LM (1997). Peabody picture vocabulary test-III. Circle Pines, MN: 
American Guidance Services. 
Gfeller, K, Turner, C, Woodworth, G, Mehr, M, Fearn, R, Witt, S, & Stordahl, J (2002). 
Recognition of familiar melodies by adult cochlear implant recipients and normal-
hearing adults. Cochlear Implants International, 3, 31. 
Gfeller, K, Witt, S, Woodworth, G, Mehr, MA, & Knutson, J (2002) Effects of frequency, 
instrumental family, and cochlear implant type on timbre recognition and 
appraisal. Annals of Otology Rhinology and Laryngology, 111: 349. 
Gfeller, KE, Olszewski, C, Turner, C, Gantz, B, & Oleson, J (2006). Music perception 
with cochlear implants and residual hearing. Audiology and Neurotology, 11 
(suppl 1): 12. 
Goldman, R & Fristoe, M (2000). Goldman-fristoe test of articulation, 2nd Edition. Circle 
Pines, MN: American Guidance Services, Inc. 
Haskins, H (1949). A phonetically balanced test of speech discrimination for children. 
Unpublished Master’s Thesis, Northwestern University, Evanston, IL. 
Hogan, C & Turner, CW (1998). High-frequency amplification: benefits for hearing-
impaired listeners. Journal of Acoustic Society of America, 104, 432-441.  
Kirk, KI, Pisoni, DB, & Osberger, MJ (1995). Lexical effects of spoken word recognition 
by pediatric cochlear implant users. Ear & Hearing, 16, 470–81. 
Mackersie, CL, Boothroyd, A, & Minniear, D (2001). Evaluation of the computer-assisted 
speech perception assessment test (CASPA). Journal of the American Academy 
of Audiology, 12, 390-96. 
Moog, JS & Geers, AE (1990). Early speech perception test. St. Louis, MO: Central 
Institute for the Deaf. 
Nadol, JB Jr, Shiao, JY, Burgess, BJ, Ketten, DR, Eddington, DK, Gantz, BJ, Kos, I, 
Montandon, P, Coker, NJ, Roland, JTJr., & Shallop, JK (2001). Histopathology of 
cochlear implants in humans. Annals of Otology, Rhinology & Laryngology, 110, 
883-91. 
Nilsson, M, Soli, SD, & Sullivan, JA (1994).  Development of the hearing in noise test for 
the measurement of speech reception thresholds in quiet and in noise. Journal of 
the Acoustical Society of America, 95, 1085-1099. 
Olszewski, C, Gfeller, K, Froman, R, Stordahl, J, Tomblin, B (2005) Familiar melody 
recognition by children and adults using cochlear implants and normal hearing 
children. Cochlear Implants International 6; 123. 
Spahr, A & Dorman, M (2005), Effects of minimum stimulation settings for the Med El 
Tempo+ speech processor on speech understanding. Ear & Hearing, 26(4) 

Iowa Cochlear Implant Clinical Research Center Hybrid Cochlear Implants in Severe to Profound Adults, 
Children, and Adolescents 
 
 
9/2011 Protocol approved by FDA (modification) 
195
(Supplement), 2S-6S. 
Swanson B, Dawson, P, & McDermott, H (2009). Investigating cochlear implant place-
pitch perception with the Modified Melodies test. Cochlear Implants International, 
10 (Supplement 1), 100. 
Tillman, TW & Carhart, R (1966).  An expanded test for speech discrimination utilizing 
CNC monosyllabic words.  Northwestern University Auditory Test No. 6 
Technical Report No. SAM-TR-66-55. USAF School of Aerospace Medicine, 
Brooks Air Force Base, Texas. 
Turner, CW & Brus, SL (2001). Providing low and mid-frequency speech information to 
listeners with sensorineural hearing loss. Journal of Acoustic Society of America, 
109, 2999-3006.  
Turner, CW (2006). Hearing loss and the limits of amplification. Audiology & 
Neurotology, 11 (suppl), 2-5. 
Turner, CW, Gantz, BJ, Vidal, C., Behrens, A, and & Henry, BA (2004). Speech 
recognition in noise for cochlear implant listeners: benefits of residual acoustic 
hearing. Journal of the Acoustical Society of America, 115, 1729-1735. 
Woodcock, R (1998). Woodcock reading mastery tests-revised/normative update. Circle 
Pines, MN: American Guidance Service.