Back to results

Safety and Effectiveness of the MED-EL Electric-Acoustic System (EAS)

Primary Purpose

Hearing Loss

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Electric Acoustic System

About this trial

This is an interventional treatment trial for Hearing Loss focused on measuring sensorineural hearing loss, ski slope audiogram, electric acoustic stimulation

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Original Audiological Criteria

Expanded Audiological Criteria

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

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.

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.

Full Information

NCT ID

NCT00747435

First Posted

September 4, 2008

Last Updated

April 10, 2017

Sponsor

Med-El Corporation

1. Study Identification

Unique Protocol Identification Number

NCT00747435

Brief Title

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

Acronym

EAS

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2017

Overall Recruitment Status

Completed

Study Start Date

February 2007 (undefined)

Primary Completion Date

February 2016 (Actual)

Study Completion Date

February 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Med-El Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hearing Loss

Keywords

sensorineural hearing loss, ski slope audiogram, electric acoustic stimulation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

73 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Original Audiological Criteria

Arm Type

Experimental

Arm Description

Arm Title

Expanded Audiological Criteria

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

Electric Acoustic System

Other Intervention Name(s)

EAS, Electric Acoustic Systems

Intervention Description

Combination of a cochlear implant and a hearing aid

Primary Outcome Measure Information:

Title

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

Description

Time Frame

12 months post initial activation

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

12 months initial activation

Title

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

Description

Time Frame

12 months post initial activation

Title

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

Description

Time Frame

12 months post initial activation

Title

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

Description

Time Frame

12 months post initial activation

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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.

Overall Study Officials: