Safety and Effectiveness of the MED-EL Electric-Acoustic System

NCT00747435 | Completed Results FDA Device

• 1 other identifier: G040002
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 14

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.

Conditions

Hearing Loss

Keywords

sensorineural hearing loss; ski slope audiogram; electric acoustic stimulation

Outcome Measures

Primary Outcomes (1)

• Improvement in Speech Perception in Noise With EAS When Compared to the Preoperative Hearing Aid Alone Condition.

  CUNY sentences in noise are scored as the percent correct of words in each sentence. The total percent correct for preoperative hearing aid use was subtracted from the total percent correct for EAS at 12 months giving a percentage point improvement in speech perception with EAS.

  12 months post initial activation

Secondary Outcomes (4)

• Improvement in Speech Perception in Noise With EAS When Compared to the Cochlear Implant Alone Condition

  12 months initial activation

• Improvement on Speech Perception in the CI-only Condition as Compared to the Preoperative With Hearing Aid Condition.

  12 months post initial activation

• Increased Benefit With EAS as Compared to Their Preoperative Hearing Aid Condition as Measured by the APHAB Questionnaire.

  12 months post initial activation

• Increase in Satisfaction With EAS Compared to Preoperative Hearing Aid Condition as Measured by the HDSS.

  12 months post initial activation

Study Arms (2)

Original Audiological Criteria

EXPERIMENTAL

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.

Device: Electric Acoustic System

Expanded Audiological Criteria

EXPERIMENTAL

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.

Device: Electric Acoustic System

Interventions

Electric Acoustic System DEVICE

Combination of a cochlear implant and a hearing aid

Also known as: EAS, Electric Acoustic Systems

Expanded Audiological Criteria; Original Audiological Criteria

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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:

You may not qualify if:

• 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.

Sponsors & Collaborators

• Med-El Corporation: lead

Study Sites (14)

Stanford University Medical Center

Stanford, California, 94035, United States

Location

University of Miami

Miami, Florida, 33136, United States

Location

Indiana University School of Medicine

Indianapolis, Indiana, 46202, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

University of Michigan

Ann Arbor, Michigan, 48108, United States

Location

Boys Town

Omaha, Nebraska, 68131, United States

Location

New York Eye & Ear

New York, New York, 10003, United States

Location

University of North Carolina Hospital

Chapel Hill, North Carolina, 27514, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Oregon Health Sciences Center

Portland, Oregon, 97239, United States

Location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Swedish Medical Center

Seattle, Washington, 98122, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Related Publications (10)

• 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.

  PMID: 17364328 BACKGROUND

• 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.

  PMID: 16864490 BACKGROUND

• Skarzynski H, Lorens A, Piotrowska A. [New method of partial deafness treatment]. Otolaryngol Pol. 2004;58(4):811-6. Polish.

  PMID: 15603395 BACKGROUND

• Skarzynski H, Lorens A, Piotrowska A. A new method of partial deafness treatment. Med Sci Monit. 2003 Apr;9(4):CS20-4.

  PMID: 12709676 BACKGROUND

• 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.

  PMID: 15724084 BACKGROUND

• 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.

  PMID: 15141755 BACKGROUND

• 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.

  PMID: 10545807 BACKGROUND

• 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.

  PMID: 17063011 BACKGROUND

• 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.

  PMID: 15224851 BACKGROUND

• 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.

  PMID: 19086194 RESULT

MeSH Terms

Conditions

Hearing Loss; Hearing Loss, Sensorineural

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Sr. Clinical Research Associate
• Organization: MED-EL Corporation

clinicaltrials@medelus.com

Study Officials

• Debra Tucci, MD

  Duke University

  PRINCIPAL INVESTIGATOR

• Christina Runge, PhD

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

• Michael Ruckenstein, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

• Hinrich Staecker, MD

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

• Peter Roland, MD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

• Oliver Adunka, MD

  University of North Carolina Hospital

  PRINCIPAL INVESTIGATOR

• Ronald Hoffman, MD

  New York Eye and Ear

  PRINCIPAL INVESTIGATOR

• Richard Miyamoto, MD

  Indiana University School of Medicine

  PRINCIPAL INVESTIGATOR

• Teresa Zwolan, PhD

  University of Michigan

  PRINCIPAL INVESTIGATOR

• Nikolas Blevins, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

• Rodney Lusk, MD

  Boys Town

  PRINCIPAL INVESTIGATOR

• Fred Telischi, MD

  University of Miami

  PRINCIPAL INVESTIGATOR

• Douglas Backous, MD

  Swedish Medical Center

  PRINCIPAL INVESTIGATOR

• Frank Warren, MD

  Oregon Health Sciences Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2008
• First Posted: September 5, 2008
• Study Start: February 1, 2007
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: May 17, 2017
• Results First Posted: May 17, 2017

Record last verified: 2017-04

Locations

US (14)