Clinical trial NCT00747435: Safety and Effectiveness of the MED-EL Electric-Acoustic System
Official title: The MED-EL EAS (Electric-Acoustic System) Using the PULSARCI100 FLEXeas / SONATATI100 FLEXeas and the DUET Speech Processor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Loss
Keywords: sensorineural hearing loss
ski slope audiogram
electric acoustic stimulation
Lead sponsor: Med-El Corporation
Sponsor class: INDUSTRY
First posted: 2008-09-05
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this investigation is to demonstrate the safety and effectiveness of the MED-EL Electric-Acoustic System (EAS), a medical device that combines the use of a cochlear implant with an external electric-acoustic processor designed to provide benefit in speech perception and sound quality to individuals with a sensorineural hearing loss with minimal changes in residual hearing. The acoustic component of the processor will aid residual acoustic hearing in low frequency ranges, while the cochlear implant and electric component of the processor will be used to electrically stimulate the auditory nerve across a wide range of frequencies necessary for speech perception.


Eligibility criteria: Inclusion Criteria:

* Audiologic tests suggest a moderate sloping to severe/profound sensorineural hearing loss in the ear to be implanted. The non-implanted ear may fall outside of these criteria; however, threshold levels cannot be better than the indication criteria (for example, the non-implanted ear must be 60 dB or poorer at 1000 Hz, 70 dB or poorer at 2000-8000 Hz).
* 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:

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.

Exclusion Criteria:

* Conductive, retrocochlear or central auditory disorders.
* 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.

Primary outcomes:
measure: Improvement in Speech Perception in Noise With EAS When Compared to the Preoperative Hearing Aid Alone Condition.
timeFrame: 12 months post initial activation
Secondary outcomes:
measure: Improvement in Speech Perception in Noise With EAS When Compared to the Cochlear Implant Alone Condition
timeFrame: 12 months initial activation
measure: Improvement on Speech Perception in the CI-only Condition as Compared to the Preoperative With Hearing Aid Condition.
timeFrame: 12 months post initial activation
measure: Increased Benefit With EAS as Compared to Their Preoperative Hearing Aid Condition as Measured by the APHAB Questionnaire.
timeFrame: 12 months post initial activation
measure: Increase in Satisfaction With EAS Compared to Preoperative Hearing Aid Condition as Measured by the HDSS.
timeFrame: 12 months post initial activation
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University Medical Center
state: California
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Indianapolis
country: United States
facility: Indiana University School of Medicine
state: Indiana
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Omaha
country: United States
facility: Boys Town
state: Nebraska
city: New York
country: United States
facility: New York Eye & Ear
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina Hospital
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Portland
country: United States
facility: Oregon Health Sciences Center
state: Oregon
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
city: Seattle
country: United States
facility: Swedish Medical Center
state: Washington
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
affiliation: Duke University
name: Debra Tucci, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical College of Wisconsin
name: Christina Runge, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pennsylvania
name: Michael Ruckenstein, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Kansas Medical Center
name: Hinrich Staecker, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Texas Southwestern Medical Center
name: Peter Roland, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of North Carolina Hospital
name: Oliver Adunka, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: New York Eye and Ear
name: Ronald Hoffman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Indiana University School of Medicine
name: Richard Miyamoto, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Michigan
name: Teresa Zwolan, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Stanford University
name: Nikolas Blevins, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Boys Town
name: Rodney Lusk, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Miami
name: Fred Telischi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Swedish Medical Center
name: Douglas Backous, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Oregon Health Sciences Center
name: Frank Warren, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
citation: Skarzynski H, Lorens A, Piotrowska A. [New method of partial deafness treatment]. Otolaryngol Pol. 2004;58(4):811-6. Polish.
citation: Skarzynski H, Lorens A, Piotrowska A. A new method of partial deafness treatment. Med Sci Monit. 2003 Apr;9(4):CS20-4.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.