Trial Outcomes & Findings for Safety and Effectiveness of the MED-EL Electric-Acoustic System (NCT NCT00747435)

NCT ID: NCT00747435

Last Updated: 2017-05-17

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 73 participants
• Primary outcome timeframe: 12 months post initial activation
• Results posted on: 2017-05-17

Participant Flow

Participant milestones

Measure	Original Audiological Criteria Originally the study was designed to have two ARMs, but the second study ARM did not fully enroll. At the time of submission, the data for both ARMs was collapsed and data analysis was completed on all subjects as one group. The below inclusion criteria represents both ARMs as one group. 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
Overall Study STARTED	73
Overall Study COMPLETED	67
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Measure	Original Audiological Criteria Originally the study was designed to have two ARMs, but the second study ARM did not fully enroll. At the time of submission, the data for both ARMs was collapsed and data analysis was completed on all subjects as one group. The below inclusion criteria represents both ARMs as one group. 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
Overall Study Lost to Follow-up	2
Overall Study Withdrawal by Subject	3
Overall Study Still undergoing follow up	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Original Audiological Criteria n=73 Participants 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
Age, Continuous	53.7 years n=73 Participants
Sex: Female, Male Female	42 Participants n=73 Participants
Sex: Female, Male Male	31 Participants n=73 Participants
Region of Enrollment United States	73 participants n=73 Participants
Duration of hearing loss	25.7 years n=73 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure

Original Audiological Criteria n=66 Participants 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

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 outcome

Timeframe: 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.

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.

Outcome measures

Measure

Original Audiological Criteria n=66 Participants 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

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 outcome

Timeframe: 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.

Outcome measures

Measure

Original Audiological Criteria n=67 Participants 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

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 23.0

SECONDARY outcome

Timeframe: 12 months post initial activation

Population: Only 59 subjects completed the APHAB at preop and 12 months post 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.

Outcome measures

Measure

Original Audiological Criteria n=59 Participants 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

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 outcome

Timeframe: 12 months post initial activation

Population: Only 59 subjects completed the HDSS at preop and 12 month post 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.

Outcome measures

Measure

Original Audiological Criteria n=59 Participants 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

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

51 Participants

Adverse Events

Original Audiological Criteria

Serious events: 10 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Measure	Original Audiological Criteria n=73 participants at risk 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
Ear and labyrinth disorders Profound/total loss of residual hearing	11.0% 8/73 • Number of events 8
Ear and labyrinth disorders Electrode migration	1.4% 1/73 • Number of events 1
Ear and labyrinth disorders Electrode lead breakage	1.4% 1/73 • Number of events 1

Other adverse events

Measure	Original Audiological Criteria n=73 participants at risk 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
Ear and labyrinth disorders Type B/Type C tympanogram	8.2% 6/73 • Number of events 8
Ear and labyrinth disorders Conductive hearing loss	6.8% 5/73 • Number of events 5
Ear and labyrinth disorders Pain at implant site	4.1% 3/73 • Number of events 3

Additional Information

Sr. Clinical Research Associate

MED-EL Corporation

Email: clinicaltrials@medelus.com

Results disclosure agreements

• Principal investigator is a sponsor employee The PI shall not publish until after the multi center publication, provided that the multi center publication is submitted within 12 months after conclusion of the study.
• Publication restrictions are in place

Restriction type: OTHER