Bilateral Cochlear Implantation in Children With the MED-EL Cochlear Implant
NCT ID: NCT00784043
Last Updated: 2018-05-25
Study Results
Results available
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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Recruitment Status
TERMINATED
Clinical Phase
NA
Total Enrollment
37 participants
Study Classification
INTERVENTIONAL
Study Start Date
2004-03-31
Study Completion Date
2017-02-28
Brief Summary
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The purpose of this study is to evaluate and document longitudinal efficacy in young children implanted bilaterally with MED-EL COMBI 40+ / PULSARCI100/SONATATI100 cochlear implant systems.
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Detailed Description
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Conditions
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Hearing Loss
Study Design
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Allocation Method
NON_RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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Bilateral
Bilaterally implanted simultaneously
Group Type
EXPERIMENTAL
Cochlear Implant
Intervention Type
DEVICE
Bilateral Implantation in children
Unilateral
Unilaterally implanted
Group Type
EXPERIMENTAL
Cochlear Implant
Intervention Type
DEVICE
Bilateral Implantation in children
Interventions
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Cochlear Implant
Bilateral Implantation in children
Intervention Type
DEVICE
Other Intervention Names
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MED-EL Cochlear Implant
Combi 40+
PulsarCI100
SonataTI100
Eligibility Criteria
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Inclusion Criteria
* Between 12 and 36 months of age at time of implantation
* Profound bilateral sensorineural hearing loss
* English as the primary language in the home
* Realistic expectations of guardians
* Child must be enrolled in a post-operative rehabilitative/educational program that supports the use of cochlear implants and the development of auditory-based skills
* Willing and available to comply with all scheduled procedures as defined in the protocol
Audiological:
* Profound bilateral sensorineural hearing loss with average thresholds between ears of 90 dB HL or greater at 1000 Hz and above, and must demonstrate minimal functional benefit from conventional amplification
* Behavioral test measures must include unaided threshold measures for the right and left ears using insert earphones; left-alone and right-alone aided sound field threshold measurements; and aided and unaided speech-awareness / detection thresholds (for each ear individually)
* Children accepted into the study must be able to demonstrate a consistent response to sound. If a child has no measurable hearing, he/she must be able to demonstrate a consistent response to vibrotactile stimuli.
* All children must have completed an appropriate trial period with optimally fit amplification prior to inclusion in the study.
Medical:
* Good general health status, as judged by Primary Investigator
* Patent cochleae bilaterally, as indicated by radiological evaluation
* No contraindications for surgery, in general, or cochlear implant surgery in particular
* Profound bilateral sensorineural hearing loss
* English as the primary language in the home
* Realistic expectations of guardians
* Child must be enrolled in a post-operative rehabilitative/educational program that supports the use of cochlear implants and the development of auditory-based skills
* Willing and available to comply with all scheduled procedures as defined in the protocol
Audiological:
* Profound bilateral sensorineural hearing loss with average thresholds between ears of 90 dB HL or greater at 1000 Hz and above, and must demonstrate minimal functional benefit from conventional amplification
* Behavioral test measures must include unaided threshold measures for the right and left ears using insert earphones; left-alone and right-alone aided sound field threshold measurements; and aided and unaided speech-awareness / detection thresholds (for each ear individually)
* Children accepted into the study must be able to demonstrate a consistent response to sound. If a child has no measurable hearing, he/she must be able to demonstrate a consistent response to vibrotactile stimuli.
* All children must have completed an appropriate trial period with optimally fit amplification prior to inclusion in the study.
Medical:
* Good general health status, as judged by Primary Investigator
* Patent cochleae bilaterally, as indicated by radiological evaluation
* No contraindications for surgery, in general, or cochlear implant surgery in particular
Exclusion Criteria
* Prior experience with any cochlear implant system
* Younger than 12 months or older than 36 months at time of implantation
* Audiological: Presence of otoacoustic emissions and/or cochlear microphonic, indicating possible condition of auditory neuropathy
Medical:
* Evidence of ossification that would prevent full insertion of the standard C40+ / PULSARCI100 /SONATATI100 electrode array in the cochlea(e) to be implanted, as indicated by radiological evaluation
* Abnormal or malformed cochlea(e) to be implanted
* Severed or non-functional auditory nerve in the ear(s) to be implanted
* Central auditory lesion
* Cognitive and/or neurological dysfunction
* Auditory neuropathy
* Younger than 12 months or older than 36 months at time of implantation
* Audiological: Presence of otoacoustic emissions and/or cochlear microphonic, indicating possible condition of auditory neuropathy
Medical:
* Evidence of ossification that would prevent full insertion of the standard C40+ / PULSARCI100 /SONATATI100 electrode array in the cochlea(e) to be implanted, as indicated by radiological evaluation
* Abnormal or malformed cochlea(e) to be implanted
* Severed or non-functional auditory nerve in the ear(s) to be implanted
* Central auditory lesion
* Cognitive and/or neurological dysfunction
* Auditory neuropathy
Minimum Eligible Age
12 Months
Maximum Eligible Age
36 Months
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Med-El Corporation
INDUSTRY
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Locations
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Nemours Children's Clinic
Jacksonville, Florida, United States
Site Status
Children's Healthcare of Atlanta
Atlanta, Georgia, United States
Site Status
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Site Status
Dallas Otolaryngology Associates
Dallas, Texas, United States
Site Status
Callier Center
Dallas, Texas, United States
Site Status
Texas Children's Hospital
Houston, Texas, United States
Site Status
Eastern Virginia Medical School
Norfolk, Virginia, United States
Site Status
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Site Status
London Health Sciences Centre
London, Ontario, Canada
Site Status
Countries
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United States
Canada
References
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Verschuur CA, Lutman ME, Ramsden R, Greenham P, O'Driscoll M. Auditory localization abilities in bilateral cochlear implant recipients. Otol Neurotol. 2005 Sep;26(5):965-71. doi: 10.1097/01.mao.0000185073.81070.07.
Reference Type
BACKGROUND
Senn P, Kompis M, Vischer M, Haeusler R. Minimum audible angle, just noticeable interaural differences and speech intelligibility with bilateral cochlear implants using clinical speech processors. Audiol Neurootol. 2005 Nov-Dec;10(6):342-52. doi: 10.1159/000087351. Epub 2005 Aug 5.
Reference Type
BACKGROUND
Sharma A, Dorman MF, Kral A. The influence of a sensitive period on central auditory development in children with unilateral and bilateral cochlear implants. Hear Res. 2005 May;203(1-2):134-43. doi: 10.1016/j.heares.2004.12.010.
Reference Type
BACKGROUND
Kuhn-Inacker H, Shehata-Dieler W, Muller J, Helms J. Bilateral cochlear implants: a way to optimize auditory perception abilities in deaf children? Int J Pediatr Otorhinolaryngol. 2004 Oct;68(10):1257-66. doi: 10.1016/j.ijporl.2004.04.029.
Reference Type
BACKGROUND
Nopp P, Schleich P, D'Haese P. Sound localization in bilateral users of MED-EL COMBI 40/40+ cochlear implants. Ear Hear. 2004 Jun;25(3):205-14. doi: 10.1097/01.aud.0000130793.20444.50.
Reference Type
BACKGROUND
Schleich P, Nopp P, D'Haese P. Head shadow, squelch, and summation effects in bilateral users of the MED-EL COMBI 40/40+ cochlear implant. Ear Hear. 2004 Jun;25(3):197-204. doi: 10.1097/01.aud.0000130792.43315.97.
Reference Type
BACKGROUND
Muller J, Schon F, Helms J. Speech understanding in quiet and noise in bilateral users of the MED-EL COMBI 40/40+ cochlear implant system. Ear Hear. 2002 Jun;23(3):198-206. doi: 10.1097/00003446-200206000-00004.
Reference Type
BACKGROUND
Schon F, Muller J, Helms J. Speech reception thresholds obtained in a symmetrical four-loudspeaker arrangement from bilateral users of MED-EL cochlear implants. Otol Neurotol. 2002 Sep;23(5):710-4. doi: 10.1097/00129492-200209000-00018.
Reference Type
BACKGROUND
Tyler RS, Gantz BJ, Rubinstein JT, Wilson BS, Parkinson AJ, Wolaver A, Preece JP, Witt S, Lowder MW. Three-month results with bilateral cochlear implants. Ear Hear. 2002 Feb;23(1 Suppl):80S-89S. doi: 10.1097/00003446-200202001-00010.
Reference Type
BACKGROUND
Winkler F, Schon F, Peklo L, Muller J, Feinen Ch, Helms J. [The Wurzburg questionnaire for assessing the quality of hearing in CI-children (WH-CIK)]. Laryngorhinootologie. 2002 Mar;81(3):211-6. doi: 10.1055/s-2002-25042. German.
Reference Type
BACKGROUND
Zimmerman-Phillips S, Robbins AM, Osberger MJ. Assessing cochlear implant benefit in very young children. Ann Otol Rhinol Laryngol Suppl. 2000 Dec;185:42-3. doi: 10.1177/0003489400109s1217. No abstract available.
Reference Type
BACKGROUND
Kirk KI, Pisoni DB, Osberger MJ. Lexical effects on spoken word recognition by pediatric cochlear implant users. Ear Hear. 1995 Oct;16(5):470-81. doi: 10.1097/00003446-199510000-00004.
Reference Type
BACKGROUND
Grantham DW, Ashmead DH, Ricketts TA, Labadie RF, Haynes DS. Horizontal-plane localization of noise and speech signals by postlingually deafened adults fitted with bilateral cochlear implants. Ear Hear. 2007 Aug;28(4):524-41. doi: 10.1097/AUD.0b013e31806dc21a.
Reference Type
BACKGROUND
Ricketts TA, Grantham DW, Ashmead DH, Haynes DS, Labadie RF. Speech recognition for unilateral and bilateral cochlear implant modes in the presence of uncorrelated noise sources. Ear Hear. 2006 Dec;27(6):763-73. doi: 10.1097/01.aud.0000240814.27151.b9.
Reference Type
BACKGROUND
Dorman MF, Dahlstrom L. Speech understanding by cochlear-implant patients with different left- and right-ear electrode arrays. Ear Hear. 2004 Apr;25(2):191-4. doi: 10.1097/01.aud.0000120367.70123.9a.
Reference Type
BACKGROUND
Laback B, Pok SM, Baumgartner WD, Deutsch WA, Schmid K. Sensitivity to interaural level and envelope time differences of two bilateral cochlear implant listeners using clinical sound processors. Ear Hear. 2004 Oct;25(5):488-500. doi: 10.1097/01.aud.0000145124.85517.e8.
Reference Type
BACKGROUND
Van Hoesel R, Ramsden R, Odriscoll M. Sound-direction identification, interaural time delay discrimination, and speech intelligibility advantages in noise for a bilateral cochlear implant user. Ear Hear. 2002 Apr;23(2):137-49. doi: 10.1097/00003446-200204000-00006.
Reference Type
BACKGROUND
Pijl S. Single-channel versus bilateral multichannel cochlear implant results: a case report. Ear Hear. 1991 Dec;12(6):431-3. doi: 10.1097/00003446-199112000-00007.
Reference Type
BACKGROUND
Beijen JW, Snik AF, Mylanus EA. Sound localization ability of young children with bilateral cochlear implants. Otol Neurotol. 2007 Jun;28(4):479-85. doi: 10.1097/MAO.0b013e3180430179.
Reference Type
BACKGROUND
Truy E, Ionescu E, Ceruse P, Gallego S. The binaural digisonic cochlear implant: surgical technique. Otol Neurotol. 2002 Sep;23(5):704-9. doi: 10.1097/00129492-200209000-00017.
Reference Type
BACKGROUND
Brown KD, Balkany TJ. Benefits of bilateral cochlear implantation: a review. Curr Opin Otolaryngol Head Neck Surg. 2007 Oct;15(5):315-8. doi: 10.1097/MOO.0b013e3282ef3d3e.
Reference Type
BACKGROUND
Das S, Buchman CA. Bilateral cochlear implantation: current concepts. Curr Opin Otolaryngol Head Neck Surg. 2005 Oct;13(5):290-3. doi: 10.1097/01.moo.0000179808.00638.ab.
Reference Type
BACKGROUND
Offeciers E, Morera C, Muller J, Huarte A, Shallop J, Cavalle L. International consensus on bilateral cochlear implants and bimodal stimulation. Acta Otolaryngol. 2005 Sep;125(9):918-9. doi: 10.1080/00016480510044412. No abstract available.
Reference Type
BACKGROUND
Laszig R, Aschendorff A, Stecker M, Muller-Deile J, Maune S, Dillier N, Weber B, Hey M, Begall K, Lenarz T, Battmer RD, Bohm M, Steffens T, Strutz J, Linder T, Probst R, Allum J, Westhofen M, Doering W. Benefits of bilateral electrical stimulation with the nucleus cochlear implant in adults: 6-month postoperative results. Otol Neurotol. 2004 Nov;25(6):958-68. doi: 10.1097/00129492-200411000-00016.
Reference Type
BACKGROUND
Litovsky RY, Parkinson A, Arcaroli J, Peters R, Lake J, Johnstone P, Yu G. Bilateral cochlear implants in adults and children. Arch Otolaryngol Head Neck Surg. 2004 May;130(5):648-55. doi: 10.1001/archotol.130.5.648.
Reference Type
BACKGROUND
Schauwers K, Gillis S, Daemers K, De Beukelaer C, De Ceulaer G, Yperman M, Govaerts PJ. Normal hearing and language development in a deaf-born child. Otol Neurotol. 2004 Nov;25(6):924-9. doi: 10.1097/00129492-200411000-00011.
Reference Type
BACKGROUND
Seeber BU, Baumann U, Fastl H. Localization ability with bimodal hearing aids and bilateral cochlear implants. J Acoust Soc Am. 2004 Sep;116(3):1698-709. doi: 10.1121/1.1776192.
Reference Type
BACKGROUND
Stark T, Engel A, Borkowski G. [Bilateral cochlea implantation in varying duration of deafness]. Laryngorhinootologie. 2004 Jan;83(1):20-2. doi: 10.1055/s-2004-814097. German.
Reference Type
BACKGROUND
Tyler RS, Witt SA, Dunn CC. Trade-offs between better hearing and better cosmetics. Am J Audiol. 2004 Dec;13(2):193-9. doi: 10.1044/1059-0889(2004/024).
Reference Type
BACKGROUND
van Hoesel RJ. Exploring the benefits of bilateral cochlear implants. Audiol Neurootol. 2004 Jul-Aug;9(4):234-46. doi: 10.1159/000078393.
Reference Type
BACKGROUND
Au DK, Hui Y, Wei WI. Superiority of bilateral cochlear implantation over unilateral cochlear implantation in tone discrimination in chinese patients. Am J Otolaryngol. 2003 Jan-Feb;24(1):19-23. doi: 10.1053/ajot.2003.8.
Reference Type
BACKGROUND
Kong W, Yu L, Xu Y, Yue J, Xiong X, Zhu L, Duan J. [Benefit of bilateral cochlear implantation on congenital prelingually deafened Chinese-speaking children]. Lin Chuang Er Bi Yan Hou Ke Za Zhi. 2003 Oct;17(10):577-9. Chinese.
Reference Type
BACKGROUND
Caleffe-Schenck, N, Franz, D. (2004). Checklist of Auditory Communication Skills. Volta Review 104(3): 175-196.
Reference Type
BACKGROUND
Semel, E, Wiig, E, Secord, W. (2003). Clinical Evaluation of Language Fundamentals Fourth Edition. San Antonio, Texas: The Psychological Corporation
Reference Type
BACKGROUND
Stark, T, Müller, J, Vischer, M, Schön, F, Senn, P, Engel, A, Kompis, M, Hildmann, H, Helms, J. (2002). Multicenter study on bilateral cochlear implantation. In Kubo, T, Takahashi, Y, Iwaki, T, (eds.) Cochlear implants - an update. The Hague: Kugler.
Reference Type
BACKGROUND
Goldman, R, Fristoe, M. (2000). Goldman-Fristoe Test of Articulation Second Edition. Circle Pines, Minnesota: American Guidance Service.
Reference Type
BACKGROUND
In Kim, C, Chang, S, Lim, D, (eds). Updates in cochlear implantation. Adv. Otorhinolarygol, Basel: Karger.
Reference Type
BACKGROUND
Lawson, D, Wilson, B, Zerbi, M, Finley, C. (1999). Fourth quarterly progress report: Speech processors for auditory prostheses. NIH Contract N01-DC-8-2105.
Reference Type
BACKGROUND
Schön, F, Mueller, J, Helms, J. (1999). Results of bilateral cochlear implantation. European Archives of Oto-Rhino-Laryngology 156:106.
Reference Type
BACKGROUND
Lawson, D, Zerbi, M, Wilson, B. (1998). First quarterly progress report: Speech processors for auditory prostheses. NIH Contract N01-DC-8-2105.
Reference Type
BACKGROUND
Dunn, L, Dunn, L. (1997). Peabody Picture Vocabulary Test Third Edition. Circle Pines, Minnesota: American Guidance Service.
Reference Type
BACKGROUND
Williams, K. (1997). Expressive Vocabulary Test. Circle Pines, Minnesota: American Guidance Service.
Reference Type
BACKGROUND
Kaufman, N. (1995). Kaufman Speech Praxis Test for Children. Detroit, Michigan: Wayne State University Press.
Reference Type
BACKGROUND
Fenson, L, Dale, P, Resnick, J, Thal, D, Bates, E, Hartung, J, Pethick, S, Reilly, J. (1993). MacArthur Communicative Development Inventories: User's Guide and Technical Manual. Baltimore, Maryland: Paul H. Brokes Publishing Company.
Reference Type
BACKGROUND
Reynell, J, Gruber, C. (1990). Reynell Developmental Language Scales. Los Angeles, California: Western Psychological Services.
Reference Type
BACKGROUND
Jerger, S, Jerger, J. (1984). Pediatric Speech Intelligibility Test. St. Louis, Missouri: Auditec of St. Louis.
Reference Type
BACKGROUND
Erber, N. (1982). Auditory Training. Washington, DC: Alexander Graham Bell Association.
Reference Type
BACKGROUND
Haskins, H. (1949). A phonetically balanced test of speech discrimination for children. Master's Theis. Northwestern University, Evanston, Illinois.
Reference Type
BACKGROUND
Ramsden R, Greenham P, O'Driscoll M, Mawman D, Proops D, Craddock L, Fielden C, Graham J, Meerton L, Verschuur C, Toner J, McAnallen C, Osborne J, Doran M, Gray R, Pickerill M. Evaluation of bilaterally implanted adult subjects with the nucleus 24 cochlear implant system. Otol Neurotol. 2005 Sep;26(5):988-98. doi: 10.1097/01.mao.0000185075.58199.22.
Reference Type
BACKGROUND
Schoen F, Mueller J, Helms J, Nopp P. Sound localization and sensitivity to interaural cues in bilateral users of the Med-El Combi 40/40+cochlear implant system. Otol Neurotol. 2005 May;26(3):429-37. doi: 10.1097/01.mao.0000169772.16045.86.
Reference Type
BACKGROUND
Long CJ, Eddington DK, Colburn HS, Rabinowitz WM. Binaural sensitivity as a function of interaural electrode position with a bilateral cochlear implant user. J Acoust Soc Am. 2003 Sep;114(3):1565-74. doi: 10.1121/1.1603765.
Reference Type
BACKGROUND
Tyler RS, Dunn CC, Witt SA, Preece JP. Update on bilateral cochlear implantation. Curr Opin Otolaryngol Head Neck Surg. 2003 Oct;11(5):388-93. doi: 10.1097/00020840-200310000-00014.
Reference Type
BACKGROUND
van Hoesel RJ, Tyler RS. Speech perception, localization, and lateralization with bilateral cochlear implants. J Acoust Soc Am. 2003 Mar;113(3):1617-30. doi: 10.1121/1.1539520.
Reference Type
BACKGROUND
Vermeire K, Brokx JP, Van de Heyning PH, Cochet E, Carpentier H. Bilateral cochlear implantation in children. Int J Pediatr Otorhinolaryngol. 2003 Jan;67(1):67-70. doi: 10.1016/s0165-5876(02)00286-0.
Reference Type
BACKGROUND
Wilson BS, Lawson DT, Muller JM, Tyler RS, Kiefer J. Cochlear implants: some likely next steps. Annu Rev Biomed Eng. 2003;5:207-49. doi: 10.1146/annurev.bioeng.5.040202.121645. Epub 2003 Apr 16.
Reference Type
BACKGROUND
Au, D., Hui, Y., Wei, W, & Wong, B. (2002). Speech recognition between bilaterally and unilaterally cochlear implanted and hearing aid fitted users. In Kubo, T., Takahashi Y., & Iwaki, T. (Ed.) Cochlear implants - an update. The Hague: Kugler.
Reference Type
BACKGROUND
Gantz BJ, Tyler RS, Rubinstein JT, Wolaver A, Lowder M, Abbas P, Brown C, Hughes M, Preece JP. Binaural cochlear implants placed during the same operation. Otol Neurotol. 2002 Mar;23(2):169-80. doi: 10.1097/00129492-200203000-00012.
Reference Type
BACKGROUND
Summerfield AQ, Marshall DH, Barton GR, Bloor KE. A cost-utility scenario analysis of bilateral cochlear implantation. Arch Otolaryngol Head Neck Surg. 2002 Nov;128(11):1255-62. doi: 10.1001/archotol.128.11.1255.
Reference Type
BACKGROUND
Mawman DJ, Ramsden RT, O'Driscoll M, Adams T, Saeed SR. Bilateral cochlear implantation--a case report. Adv Otorhinolaryngol. 2000;57:360-3. doi: 10.1159/000059132. No abstract available.
Reference Type
BACKGROUND
Mueller J, Schoen F, Helms J. Bilateral cochlear implant--new aspects for the future? Adv Otorhinolaryngol. 2000;57:22-7. doi: 10.1159/000059172. No abstract available.
Reference Type
BACKGROUND
Lawson, D., Wilson, B., Zerbi, M., & Finley, C. (1999). Fourth Quarterly Progress Report. NIH Contract N01-DC-8-2105. Retrieved from http://npp.ninds.nih.gov/ProgressReports/Speech ProcessorsforAuditoryProstheses%20DC82105/SpeechProcessorsWilson4DC82105.pdf
Reference Type
BACKGROUND
van Hoesel, R. J. M., & Clark, G. M. (1999). Speech results with a bilateral multi-channel cochlear implant subject for spatially separated signal and noise. Australian Journal of Audiology, 21, 23-28.
Reference Type
BACKGROUND
Müller, J., Schön, F., & Helms J. (1998). Binaural cochlear implantation: a case report discussing preliminary results. European Archives of Oto-Rhino-Laryngology, 255, 38.
Reference Type
BACKGROUND
Lawson DT, Wilson BS, Zerbi M, van den Honert C, Finley CC, Farmer JC Jr, McElveen JT Jr, Roush PA. Bilateral cochlear implants controlled by a single speech processor. Am J Otol. 1998 Nov;19(6):758-61.
Reference Type
BACKGROUND
Lawson, D., Zerbi, M., & Wilson, B. (1998). First Quarterly Progress Report. NIH Contract N01-DC-8-2105. Retrieved from http://npp.ninds.nih.gov/ProgressReports/SpeechProcessorsfor AuditoryProstheses%20DC82105/qpr1/qpr1a.html
Reference Type
BACKGROUND
van Hoesel RJ, Clark GM. Psychophysical studies with two binaural cochlear implant subjects. J Acoust Soc Am. 1997 Jul;102(1):495-507. doi: 10.1121/1.419611.
Reference Type
BACKGROUND
Lawson, D., Wilson, B., Zerbi, M., & Finley, C. (1996). Fifth Quarterly Progress Report. NIH Contract N01-DC-5-2103. Retrieved from http://npp.ninds.nih.gov/ProgressReports/Speech ProcessorsforAuditoryProstheses%20DC52103/qpr5/qpr5.html.
Reference Type
BACKGROUND
Van Hoesel RJ, Clark GM. Fusion and lateralization study with two binaural cochlear implant patients. Ann Otol Rhinol Laryngol Suppl. 1995 Sep;166:233-5.
Reference Type
BACKGROUND
van Hoesel RJ, Tong YC, Hollow RD, Clark GM. Psychophysical and speech perception studies: a case report on a binaural cochlear implant subject. J Acoust Soc Am. 1993 Dec;94(6):3178-89. doi: 10.1121/1.407223.
Reference Type
BACKGROUND
Green JD Jr, Mills DM, Bell BA, Luxford WM, Tonokawa LL. Binaural cochlear implants. Am J Otol. 1992 Nov;13(6):502-6.
Reference Type
BACKGROUND
Pelizzone M, Kasper A, Montandon P. Binaural interaction in a cochlear implant patient. Hear Res. 1990 Oct;48(3):287-90. doi: 10.1016/0378-5955(90)90069-2.
Reference Type
BACKGROUND
Balkany T, Boggess W, Dinner B. Binaural cochlear implantation: comparison of 3M/House and Nucleus 22 devices with evidence of sensory integration. Laryngoscope. 1988 Oct;98(10):1040-3. doi: 10.1288/00005537-198810000-00002.
Reference Type
BACKGROUND
Other Identifiers
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MED-EL NA 013
Identifier Type: -
Identifier Source: org_study_id
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