Hearing Loss
Conditions
Keywords
sensorineural hearing loss, ski slope audiogram, electric acoustic stimulation
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.
Interventions
DEVICEElectric Acoustic System
Combination of a cochlear implant and a hearing aid
Sponsors
Med-El Corporation
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in Speech Perception in Noise With EAS When Compared to the Preoperative Hearing Aid Alone Condition. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in Speech Perception in Noise With EAS When Compared to the Cochlear Implant Alone Condition | 12 months initial activation | 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. | 12 months post initial activation | 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. | 12 months post initial activation | 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. | 12 months post initial activation | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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: 0 0 0 0 0 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 ≤60% in the best-aided condition.
Electric Acoustic System: Combination of a cochlear implant and a hearing aid | 73 |
| Total | 73 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 2 |
| Overall Study | Still undergoing follow up | 1 |
| Overall Study | Withdrawal by Subject | 3 |
Baseline characteristics
| Characteristic | Original Audiological Criteria | — |
|---|---|---|
| Age, Continuous | 53.7 years | — |
| Duration of hearing loss | 25.7 years | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 73 participants | — |
| Sex: Female, Male Female | 42 Participants | — |
| Sex: Female, Male Male | 31 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 73 |
| other Total, other adverse events | 14 / 73 |
| serious Total, serious adverse events | 10 / 73 |
Outcome results
Primary
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.
Time frame: 12 months post initial activation
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Original Audiological Criteria | Improvement in Speech Perception in Noise With EAS When Compared to the Preoperative Hearing Aid Alone Condition. | 42.2 percentage of words correct (CUNY) | Standard Deviation 29.8 |
Secondary
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.
Time frame: 12 months initial activation
Population: One subject lost residual hearing immediately after surgery and was unable to use EAS. The subject was testing in cochlear implant alone condition.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Original Audiological Criteria | Improvement in Speech Perception in Noise With EAS When Compared to the Cochlear Implant Alone Condition | 18.4 percentage of words correct (CUNY) | Standard Deviation 22.03 |
Secondary
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.
Time frame: 12 months post initial activation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Original Audiological Criteria | Improvement on Speech Perception in the CI-only Condition as Compared to the Preoperative With Hearing Aid Condition. | 18.0 percentage of words correct (CNC) | Standard Deviation 23 |
Secondary
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.
Time frame: 12 months post initial activation
Population: Only 59 subjects completed the APHAB at preop and 12 months post activation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Original Audiological Criteria | Increased Benefit With EAS as Compared to Their Preoperative Hearing Aid Condition as Measured by the APHAB Questionnaire. | -30.2 percentage of scoring change (APHAB) | Standard Deviation 20.4 |
Secondary
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.
Time frame: 12 months post initial activation
Population: Only 59 subjects completed the HDSS at preop and 12 month post activation.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Original Audiological Criteria | Increase in Satisfaction With EAS Compared to Preoperative Hearing Aid Condition as Measured by the HDSS. | 51 Participants |