Hearing LossEASNCT00747435

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

A study testing Electric Acoustic System in people with Hearing Loss, run by Med-El Corporation at 14 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Hearing Loss
What is being tested?: Electric Acoustic System
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 73 participants
Where: 14 sitesUnited States
Study dates: Feb 2007to Feb 2016
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Show all 17Show fewer

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.

Who cannot join

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.

Trial locations and contacts

14 sites in 1 country.

City, postcode or hospital

14 sites in 1 country

United States14 sites

University of Michigan
Ann Arbor, Michigan, 48108
University of North Carolina Hospital
Chapel Hill, North Carolina, 27514
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
Duke University Medical Center
Durham, North Carolina, 27710
Indiana University School of Medicine
Indianapolis, Indiana, 46202
University of Kansas Medical Center
Kansas City, Kansas, 66160
University of Miami
Miami, Florida, 33136
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
New York Eye & Ear
New York, New York, 10003
Boys Town
Omaha, Nebraska, 68131
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Oregon Health Sciences Center
Portland, Oregon, 97239
Swedish Medical Center
Seattle, Washington, 98122
Stanford University Medical Center
Stanford, California, 94035

Other trials in United States

About this study

Official title: The MED-EL EAS (Electric-Acoustic System) Using the PULSARCI100 FLEXeas / SONATATI100 FLEXeas and the DUET Speech Processor

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
Being tested: Electric Acoustic System
Keywords: sensorineural hearing loss, ski slope audiogram, electric acoustic stimulation
Medical subject headings: Hearing Loss, Hearing Loss, Sensorineural

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Electric Acoustic SystemDevice
Also called EAS, Electric Acoustic Systems
Combination of a cochlear implant and a hearing aid

Study groups in NCT00747435
Study group	Role	What they receive
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. Receives: 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. Receives: Device: Electric Acoustic System

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 12 months post initial activation

Secondary outcomes (4)

Improvement in Speech Perception in Noise With EAS When Compared to the Cochlear Implant Alone Condition
CUNY sentences in noise are scored as the percent correct of words in each sentence. The total percent correct for the CI Alone condition was subtracted from the total percent correct for the EAS condition at 12 months giving an improvement in speech perception with EAS compared to CI Alone.
Measured: 12 months initial activation
Improvement on Speech Perception in the CI-only Condition as Compared to the Preoperative With Hearing Aid Condition.
CNC words are scored as the percent correct out of 50 words. The percent correct for preoperative hearing aid use was subtracted from the percent correct for CI Alone at 12 months giving an improvement on speech perception for CI Alone compared to preoperative hearing aids.
Measured: 12 months post initial activation
Increased Benefit With EAS as Compared to Their Preoperative Hearing Aid Condition as Measured by the APHAB Questionnaire.
A lower score on the APHAB indicates a better performance. The global score for preoperative hearing aid use was subtracted from the global score for EAS at 12 months giving an improvement on the APHAB with EAS.
Measured: 12 months post initial activation
Increase in Satisfaction With EAS Compared to Preoperative Hearing Aid Condition as Measured by the HDSS.
Satisfaction is ranked from 1-5, with 1 being very dissatisfied and 5 being very satisfied. Data reported is the percentage of subjects who experienced an increase in satisfaction when using EAS compared to preoperative hearing aids.
Measured: 12 months post initial activation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2007Feb 2016

First posted5 Sep 2008 (estimated)
Study startFeb 2007
Primary completionFeb 2016
Study completionFeb 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (10)Papers the sponsor has linked to this study.
Other trials for Hearing LossStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 73 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00747435
Sponsor's protocol ID: G040002
Acronym: EAS
Status last verified: Apr 2017
First submitted: 4 Sep 2008
Last updated: 17 May 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes

Publications

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.
PubMed 17364328
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.
PubMed 16864490
Skarzynski H, Lorens A, Piotrowska A. [New method of partial deafness treatment]. Otolaryngol Pol. 2004;58(4):811-6. Polish.
PubMed 15603395
Skarzynski H, Lorens A, Piotrowska A. A new method of partial deafness treatment. Med Sci Monit. 2003 Apr;9(4):CS20-4.
PubMed 12709676
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.
PubMed 15724084
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.
PubMed 15141755
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.
PubMed 10545807
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.
PubMed 17063011
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.
PubMed 15224851
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.
PubMed 19086194

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 17 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The MED-EL EAS (Electric-Acoustic System) Using the PULSARCI100 FLEXeas / SONATATI100 FLEXeas and the DUET Speech Processor
ClinicalTrials.gov ID: NCT00747435
Acronym / sponsor ID: EAS / G040002
Conditions: Hearing Loss
Keywords: sensorineural hearing loss, ski slope audiogram, electric acoustic stimulation
Study type: Interventional
Recruitment status: Completed
Enrolment: 73 participants (actual)
Lead sponsor: Med-El CorporationIndustry (pharma, biotech, devices)
Study start: Feb 2007
Primary completion: Feb 2016 (actual)
Study completion: Feb 2016 (actual)
First posted: 5 Sep 2008 (estimated)
Results: Posted 17 May 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Original Audiological Criteria	Experimental	Device: Electric Acoustic SystemInclusion 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.
Expanded Audiological Criteria	Experimental	Device: Electric Acoustic SystemPure-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.

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (17 listed)

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.

Key exclusion criteria (6 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Electric Acoustic SystemAlso: EAS, Electric Acoustic SystemsCombination of a cochlear implant and a hearing aid	Device	Expanded Audiological Criteria, Original Audiological Criteria

Primary outcome

Improvement in Speech Perception in Noise With EAS When Compared to the Preoperative Hearing Aid Alone Condition.
Time frame: 12 months post initial activation
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.

4 secondary outcomes

Improvement in Speech Perception in Noise With EAS When Compared to the Cochlear Implant Alone Condition
Time frame: 12 months initial activation
Improvement on Speech Perception in the CI-only Condition as Compared to the Preoperative With Hearing Aid Condition.
Time frame: 12 months post initial activation
Increased Benefit With EAS as Compared to Their Preoperative Hearing Aid Condition as Measured by the APHAB Questionnaire.
Time frame: 12 months post initial activation
Increase in Satisfaction With EAS Compared to Preoperative Hearing Aid Condition as Measured by the HDSS.
Time frame: 12 months post initial activation

Results and safety

Results posted to the registry on 17 May 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Original Audiological Criteria	73	67

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

Time frame: 12 months post initial activation. Least squares mean (Standard Deviation). Unit: percentage of words correct (CUNY)

Measure	Original Audiological Criteria n = 66
Value	42.2 (29.8)

Population analysed: One subject lost residual hearing immediately following surgery and was unable to use EAS. This subject was tested with the cochlear implant alone and is not included in this analysis.

4 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 4% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Original Audiological Criteria	10 of 73 (13.7%)	14 of 73 (19.2%)	0 of 73

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 17364328Skarzynski 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.
Background: PubMed 16864490Skarzynski 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.
Background: PubMed 15603395Skarzynski H, Lorens A, Piotrowska A. [New method of partial deafness treatment]. Otolaryngol Pol. 2004;58(4):811-6. Polish.
Background: PubMed 12709676Skarzynski H, Lorens A, Piotrowska A. A new method of partial deafness treatment. Med Sci Monit. 2003 Apr;9(4):CS20-4.
Background: PubMed 15724084Kiefer 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.
Background: PubMed 15141755Kiefer 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.
Background: PubMed 10545807von 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.
Background: PubMed 17063011Gstoettner 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.
Background: PubMed 15224851Gstoettner 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.
Results publication: PubMed 19086194Gstoettner 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Debra Tucci, MD principal investigator

Duke University

Christina Runge, PhD principal investigator

Medical College of Wisconsin

Michael Ruckenstein, MD principal investigator

University of Pennsylvania

14 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Electric Acoustic System in people with Hearing Loss, run by Med-El Corporation at 14 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 May 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Improvement in Speech Perception in Noise With EAS When Compared to the Preoperative Hearing Aid Alone Condition. (time frame: 12 months post initial activation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00747435, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2017.