Safety and Effectiveness of the MED-EL Electric-Acoustic System
NCT ID: NCT00747435
Last Updated: 2017-05-17
Study Results
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View full resultsBasic Information
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COMPLETED
NA
73 participants
INTERVENTIONAL
2007-02-28
2016-02-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Original Audiological Criteria
Inclusion Criteria:
Pure-tone air-conduction threshold levels shall fall at or within the levels listed in the following chart.
Frequency (Hz): 250 500 750 1000 1500 2000 4000 8000 Lower Limit: 10 10 10 60 60 70 70 70 Upper Limit: 65 65 75 \*110+ \*110+\*110+ \*110+ \*90+
Minimal benefit from optimally fit hearing aid/s, preferably bilateral, with monosyllabic word scores in quiet of ≤50% in the best-aided condition.
Electric Acoustic System
Combination of a cochlear implant and a hearing aid
Expanded Audiological Criteria
Pure-tone air-conduction threshold levels shall fall at or within the levels listed in the following chart.
Frequency (Hz): 250 500 750 1000 1500 2000 4000 8000 Lower Limit: 10 10 10 60 60 70 70 70 Upper Limit: 65 65 75 \*110+ \*110+\*110+ \*110+ \*90+
Minimal benefit from optimally fit hearing aid/s, preferably bilateral, with monosyllabic word scores in quiet of ≤50% in the best-aided condition.
Study Arm 2 candidates are those who meet the inclusion criteria listed above with the exception that:
In the ear to be implanted, the pure-tone air conduction threshold(s) at 250, 500, and/or 750 Hz will be greater than or equal to 0 dB HL and less than 10 dB HL, and/or In the ear to be implanted, the pure-tone air conduction threshold(s) at 1000 and/or 1500 Hz will be greater than or equal to 0 dB HL and less than 60 dB HL and/or In their best-aided condition, they score 51-60% on monosyllabic word scores.
Electric Acoustic System
Combination of a cochlear implant and a hearing aid
Interventions
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Electric Acoustic System
Combination of a cochlear implant and a hearing aid
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Pure-tone air-conduction threshold levels for the ear to be implanted shall fall at or within the following levels:
250 Hz - 500 Hz hearing loss less than or equal to 65 dB HL 750 Hz hearing loss less than or equal to 75 dB HL 1000-1500 Hz hearing loss less than or equal to 60 dBHL (ie. 60-110+ dB HL) 2000 Hz - 8000 Hz hearing loss less than or equal to 70 dB HL
* Pure-tone air-conduction threshold levels shall fall at or within the levels listed in the following chart Frequency (Hz): 250 500 750 1000 1500 2000 4000 8000 Lower Limit: 10 10 10 60 60 70 70 70 Upper Limit: 65 65 75 \*110+ \*110+ \*110+ \*110+ \*90+
* Pure-tone air-conduction thresholds for both ears are within 20 dB of each other at 250, 500 and 1000 Hz.
* Air-bone gap at 500, 1000, 2000 and 4000 Hz should be \<10 dB at two or more of these frequencies.
* Minimal benefit from optimally fit hearing aid/s, preferably bilateral, with monosyllabic word scores in quiet of ≤50% in the best-aided condition.
* Normal middle ear anatomy and function (based on clinical assessment of tympanometry and acoustic reflex results). No prior middle ear surgery or history of postadolescent, chronic middle ear infections or inner ear disorders (i.e. vertigo or Meniere's syndrome).
* No evidence that hearing loss origin is retrocochlear.
* Current user of bilateral acoustic hearing aids for at least 3 months. Note: If the subject has not been a successful hearing aid user (i.e. improper fit, feedback and/or discomfort from high frequency amplification), he/she must complete a hearing aid trial in the ear to be implanted for at least 1 month. If the ear to be implanted is poorer than the contralateral ear, then the subject must complete a hearing aid trial in both ears for at least 1 month to ensure that he/she is tested in the best-aided condition.
* Adults 18-70 years of age at time of implantation.
* Persons who currently exhibit sufficient understanding and communicative skills to comprehend general conversation in an "oral/aural mode" through normal conversation channels.
* English as primary language.
* Appropriate motivation and expectation levels.
Expanded Criteria:
In the ear to be implanted, the pure-tone air conduction threshold(s) at 250, 500, and/or 750 Hz will be greater than or equal to 0 dB HL and less than 10 dB HL, and/or In the ear to be implanted, the pure-tone air conduction threshold(s) at 1000 and/or 1500 Hz will be greater than or equal to 0 dB HL and less than 60 dB HL and/or In their best-aided condition, they score 51-60% on monosyllabic word scores.
Exclusion Criteria
* Hearing loss in the ear to be implanted that has demonstrated a recent fluctuation at two or more frequencies of 15 dB in either direction in the last 2 years as demonstrated by serial audiograms. Note: In cases where 2-year documentation is missing, documentation of at least 18 months is necessary along with patient report of no fluctuation in the past 2 years. If 18-month data is unavailable, the patient must be monitored until 18-month data is available.
* Any physical, psychological, or emotional disorder that would interfere with surgery or the ability to perform on test and rehabilitation procedures.
* Developmental delays or organic brain dysfunction.
* Physical or geographic limitations that may interfere with the completion of scheduled follow-up evaluations.
* Skin or scalp conditions that could preclude magnetic attachment of the speech processor or use of the acoustic hearing aid.
18 Years
70 Years
ALL
No
Sponsors
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Med-El Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Debra Tucci, MD
Role: PRINCIPAL_INVESTIGATOR
Duke University
Christina Runge, PhD
Role: PRINCIPAL_INVESTIGATOR
Medical College of Wisconsin
Michael Ruckenstein, MD
Role: PRINCIPAL_INVESTIGATOR
University of Pennsylvania
Hinrich Staecker, MD
Role: PRINCIPAL_INVESTIGATOR
University of Kansas Medical Center
Peter Roland, MD
Role: PRINCIPAL_INVESTIGATOR
University of Texas Southwestern Medical Center
Oliver Adunka, MD
Role: PRINCIPAL_INVESTIGATOR
University of North Carolina Hospital
Ronald Hoffman, MD
Role: PRINCIPAL_INVESTIGATOR
New York Eye and Ear
Richard Miyamoto, MD
Role: PRINCIPAL_INVESTIGATOR
Indiana University School of Medicine
Teresa Zwolan, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Michigan
Nikolas Blevins, MD
Role: PRINCIPAL_INVESTIGATOR
Stanford University
Rodney Lusk, MD
Role: PRINCIPAL_INVESTIGATOR
Boys Town
Fred Telischi, MD
Role: PRINCIPAL_INVESTIGATOR
University of Miami
Douglas Backous, MD
Role: PRINCIPAL_INVESTIGATOR
Swedish Medical Center
Frank Warren, MD
Role: PRINCIPAL_INVESTIGATOR
Oregon Health Sciences Center
Locations
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Stanford University Medical Center
Stanford, California, United States
University of Miami
Miami, Florida, United States
Indiana University School of Medicine
Indianapolis, Indiana, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
University of Michigan
Ann Arbor, Michigan, United States
Boys Town
Omaha, Nebraska, United States
New York Eye & Ear
New York, New York, United States
University of North Carolina Hospital
Chapel Hill, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
Oregon Health Sciences Center
Portland, Oregon, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
Swedish Medical Center
Seattle, Washington, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Countries
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References
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Skarzynski H, Lorens A, Piotrowska A, Anderson I. Preservation of low frequency hearing in partial deafness cochlear implantation (PDCI) using the round window surgical approach. Acta Otolaryngol. 2007 Jan;127(1):41-8. doi: 10.1080/00016480500488917.
Skarzynski H, Lorens A, Piotrowska A, Anderson I. Partial deafness cochlear implantation provides benefit to a new population of individuals with hearing loss. Acta Otolaryngol. 2006 Sep;126(9):934-40. doi: 10.1080/00016480600606632.
Skarzynski H, Lorens A, Piotrowska A. [New method of partial deafness treatment]. Otolaryngol Pol. 2004;58(4):811-6. Polish.
Skarzynski H, Lorens A, Piotrowska A. A new method of partial deafness treatment. Med Sci Monit. 2003 Apr;9(4):CS20-4.
Kiefer J, Pok M, Adunka O, Sturzebecher E, Baumgartner W, Schmidt M, Tillein J, Ye Q, Gstoettner W. Combined electric and acoustic stimulation of the auditory system: results of a clinical study. Audiol Neurootol. 2005 May-Jun;10(3):134-44. doi: 10.1159/000084023. Epub 2005 Feb 17.
Kiefer J, Gstoettner W, Baumgartner W, Pok SM, Tillein J, Ye Q, von Ilberg C. Conservation of low-frequency hearing in cochlear implantation. Acta Otolaryngol. 2004 Apr;124(3):272-80. doi: 10.1080/00016480310000755a.
von Ilberg C, Kiefer J, Tillein J, Pfenningdorff T, Hartmann R, Sturzebecher E, Klinke R. Electric-acoustic stimulation of the auditory system. New technology for severe hearing loss. ORL J Otorhinolaryngol Relat Spec. 1999 Nov-Dec;61(6):334-40. doi: 10.1159/000027695.
Gstoettner WK, Helbig S, Maier N, Kiefer J, Radeloff A, Adunka OF. Ipsilateral electric acoustic stimulation of the auditory system: results of long-term hearing preservation. Audiol Neurootol. 2006;11 Suppl 1:49-56. doi: 10.1159/000095614. Epub 2006 Oct 6.
Gstoettner W, Kiefer J, Baumgartner WD, Pok S, Peters S, Adunka O. Hearing preservation in cochlear implantation for electric acoustic stimulation. Acta Otolaryngol. 2004 May;124(4):348-52. doi: 10.1080/00016480410016432.
Gstoettner WK, van de Heyning P, O'Connor AF, Morera C, Sainz M, Vermeire K, Mcdonald S, Cavalle L, Helbig S, Valdecasas JG, Anderson I, Adunka OF. Electric acoustic stimulation of the auditory system: results of a multi-centre investigation. Acta Otolaryngol. 2008 Sep;128(9):968-75. doi: 10.1080/00016480701805471.
Other Identifiers
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G040002
Identifier Type: -
Identifier Source: org_study_id
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