Trial Outcomes & Findings for The Esteem® Hearing Implant Post Approval Study (NCT NCT02666222)
NCT ID: NCT02666222
Last Updated: 2016-05-04
Results Overview
ENDPOINT #1: SRT at baseline minus SRT at Year 5. Positive difference (i.e. lower value of SRT with the Esteem) indicates better outcome.
Recruitment status
COMPLETED
Target enrollment
51 participants
Primary outcome timeframe
Baseline through Year 5 of Follow Up
Results posted on
2016-05-04
Participant Flow
Participant milestones
| Measure |
Esteem Implant
Subjects implanted with the Esteem Totally Implantable Hearing System
|
|---|---|
|
Overall Study
STARTED
|
51
|
|
Overall Study
COMPLETED
|
49
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Esteem Implant
Subjects implanted with the Esteem Totally Implantable Hearing System
|
|---|---|
|
Overall Study
Death
|
2
|
Baseline Characteristics
The Esteem® Hearing Implant Post Approval Study
Baseline characteristics by cohort
| Measure |
Esteem Implant
n=51 Participants
Subjects implanted with the Esteem Totally Implantable Hearing System
|
|---|---|
|
Age, Continuous
|
56.1 years
STANDARD_DEVIATION 15.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White/Caucasian
|
50 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black/Non-Hispanic
|
0 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
0 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline through Year 5 of Follow UpPopulation: 5 Year Follow-up
ENDPOINT #1: SRT at baseline minus SRT at Year 5. Positive difference (i.e. lower value of SRT with the Esteem) indicates better outcome.
Outcome measures
| Measure |
Esteem Implant
n=49 Participants
Subjects implanted with the Esteem Totally Implantable Hearing System
|
|---|---|
|
Change From Baseline (Pre-implant Aided Condition) at Year 5 in Speech Reception Threshold (SRT)
|
4.8 dB
Standard Error 2
|
PRIMARY outcome
Timeframe: Baseline through Year 5 of Follow UpPopulation: 5 Year Follow-up Visit
ENDPOINT #2: WRS at Year 5 minus WRS at baseline. Positive difference (in % correct) indicates better outcome.
Outcome measures
| Measure |
Esteem Implant
n=49 Participants
Subjects implanted with the Esteem Totally Implantable Hearing System
|
|---|---|
|
Change From Baseline (Pre-implant Aided Condition) at Year 5 in Word Recognition Score (WRS) at 50 dB HL
|
17 percentage of correct responses
Standard Error 4.2
|
PRIMARY outcome
Timeframe: SADEs, PAS phase through Year 5 of Follow UpPopulation: Cumulative through 5-Year Follow-up
ENDPOINT #3: The analysis of the incidence of SADEs and device failures and replacements at each follow-up.
Outcome measures
| Measure |
Esteem Implant
n=51 Participants
Subjects implanted with the Esteem Totally Implantable Hearing System
|
|---|---|
|
Incidence of Serious Adverse Device Events (SADEs) and Device Failures and Replacements at Each Follow-up.
|
3 participants
|
PRIMARY outcome
Timeframe: Baseline through 5 Year Follow-UpPopulation: Difference between Baseline and 5 Year PTA (average of 500, 1000, 2000 Hz thresholds)
ENDPOINT #5: Difference between Baseline and 5 Year Pure-Tone Average (PTA; average of 500, 1000, 2000 Hz thresholds); calculated as PTA at Year 5 minus PTA at baseline. Smaller magnitude dB difference indicates better outcome.
Outcome measures
| Measure |
Esteem Implant
n=49 Participants
Subjects implanted with the Esteem Totally Implantable Hearing System
|
|---|---|
|
Bone Conduction Stability
|
3.7 dB
Standard Error 1.1
|
SECONDARY outcome
Timeframe: Baseline through Year 5 of Follow UpPopulation: 5 Year Follow-up
APHAB results were obtained from baseline aided condition through Year 5 of follow up. The APHAB responses are in terms of percent of time an individual experiences problems, on a scale of 0-100%; lower scores indicate fewer problems.Compared scores with Esteem to scores in baseline aided condition, calculated as APHAB Global score at baseline minus APHAB Global score at Year 5, giving a "difference in benefit" score. The Global Score is the mean of the scores (% of problems) for Ease of Communication (EC), Reverberation (RV), and Background Noise (BN) subscales of the APHAB. A positive difference in benefit score indicates more benefit with Esteem.
Outcome measures
| Measure |
Esteem Implant
n=47 Participants
Subjects implanted with the Esteem Totally Implantable Hearing System
|
|---|---|
|
Improvement in Quality of Life as Reflected by Abbreviated Profile of Hearing Aid Benefit (APHAB) Questionnaire
|
5.6 difference score in units on a scale
Interval 0.4 to 10.9
|
Adverse Events
Esteem Implant
Serious events: 14 serious events
Other events: 42 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Esteem Implant
n=51 participants at risk
Subjects implanted with the Esteem Totally Implantable Hearing System
|
|---|---|
|
Skin and subcutaneous tissue disorders
Sore behind ear
|
2.0%
1/51 • Number of events 1 • PAS phase through 5 years
All Adverse Events adjudicated by Clinical Events Committee
|
|
General disorders
Exposed Leads
|
2.0%
1/51 • Number of events 1 • PAS phase through 5 years
All Adverse Events adjudicated by Clinical Events Committee
|
|
Infections and infestations
Infected Implant Site
|
2.0%
1/51 • Number of events 1 • PAS phase through 5 years
All Adverse Events adjudicated by Clinical Events Committee
|
|
Gastrointestinal disorders
Gall bladder removal surgery
|
2.0%
1/51 • Number of events 1 • PAS phase through 5 years
All Adverse Events adjudicated by Clinical Events Committee
|
|
Nervous system disorders
Multiple sclerosis
|
2.0%
1/51 • Number of events 1 • PAS phase through 5 years
All Adverse Events adjudicated by Clinical Events Committee
|
|
Surgical and medical procedures
Cancer treatment
|
2.0%
1/51 • Number of events 1 • PAS phase through 5 years
All Adverse Events adjudicated by Clinical Events Committee
|
|
Musculoskeletal and connective tissue disorders
Disc displacement
|
2.0%
1/51 • Number of events 1 • PAS phase through 5 years
All Adverse Events adjudicated by Clinical Events Committee
|
|
Injury, poisoning and procedural complications
Fell and broke collarbone, clavicle & 3 ribs. Slight lung puncture.
|
2.0%
1/51 • Number of events 1 • PAS phase through 5 years
All Adverse Events adjudicated by Clinical Events Committee
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer
|
2.0%
1/51 • Number of events 1 • PAS phase through 5 years
All Adverse Events adjudicated by Clinical Events Committee
|
|
Surgical and medical procedures
Shoulder surgery
|
2.0%
1/51 • Number of events 1 • PAS phase through 5 years
All Adverse Events adjudicated by Clinical Events Committee
|
|
Musculoskeletal and connective tissue disorders
Spinal stenosis
|
2.0%
1/51 • Number of events 1 • PAS phase through 5 years
All Adverse Events adjudicated by Clinical Events Committee
|
|
Social circumstances
Death
|
3.9%
2/51 • Number of events 2 • PAS phase through 5 years
All Adverse Events adjudicated by Clinical Events Committee
|
|
Ear and labyrinth disorders
Tinnitus
|
2.0%
1/51 • Number of events 1 • PAS phase through 5 years
All Adverse Events adjudicated by Clinical Events Committee
|
Other adverse events
| Measure |
Esteem Implant
n=51 participants at risk
Subjects implanted with the Esteem Totally Implantable Hearing System
|
|---|---|
|
Ear and labyrinth disorders
Distortion
|
2.0%
1/51 • Number of events 1 • PAS phase through 5 years
All Adverse Events adjudicated by Clinical Events Committee
|
|
Nervous system disorders
Facial Tingling and Weakness
|
2.0%
1/51 • Number of events 1 • PAS phase through 5 years
All Adverse Events adjudicated by Clinical Events Committee
|
|
General disorders
Feedback
|
2.0%
1/51 • Number of events 1 • PAS phase through 5 years
All Adverse Events adjudicated by Clinical Events Committee
|
|
Skin and subcutaneous tissue disorders
Incision Site Pain/Soreness
|
3.9%
2/51 • Number of events 2 • PAS phase through 5 years
All Adverse Events adjudicated by Clinical Events Committee
|
|
Ear and labyrinth disorders
Low Performance
|
2.0%
1/51 • Number of events 1 • PAS phase through 5 years
All Adverse Events adjudicated by Clinical Events Committee
|
|
Skin and subcutaneous tissue disorders
Mild Discomfort at Processor Site
|
2.0%
1/51 • Number of events 1 • PAS phase through 5 years
All Adverse Events adjudicated by Clinical Events Committee
|
|
Skin and subcutaneous tissue disorders
Pain Around Processor Ridge
|
2.0%
1/51 • Number of events 1 • PAS phase through 5 years
All Adverse Events adjudicated by Clinical Events Committee
|
|
Ear and labyrinth disorders
Positional Vertigo
|
2.0%
1/51 • Number of events 1 • PAS phase through 5 years
All Adverse Events adjudicated by Clinical Events Committee
|
|
Skin and subcutaneous tissue disorders
Postauricular skin "shrink-wrapped" around leads
|
2.0%
1/51 • Number of events 1 • PAS phase through 5 years
All Adverse Events adjudicated by Clinical Events Committee
|
|
Skin and subcutaneous tissue disorders
Tenderness and drainage at incision site
|
2.0%
1/51 • Number of events 1 • PAS phase through 5 years
All Adverse Events adjudicated by Clinical Events Committee
|
|
General disorders
Neck pain
|
2.0%
1/51 • Number of events 1 • PAS phase through 5 years
All Adverse Events adjudicated by Clinical Events Committee
|
|
Ear and labyrinth disorders
Poorly performing implant
|
2.0%
1/51 • Number of events 1 • PAS phase through 5 years
All Adverse Events adjudicated by Clinical Events Committee
|
|
General disorders
Premature battery depletion
|
2.0%
1/51 • Number of events 1 • PAS phase through 5 years
All Adverse Events adjudicated by Clinical Events Committee
|
|
Ear and labyrinth disorders
Reduced performance
|
2.0%
1/51 • Number of events 1 • PAS phase through 5 years
All Adverse Events adjudicated by Clinical Events Committee
|
|
Ear and labyrinth disorders
Abscess left external auditory canal
|
2.0%
1/51 • Number of events 1 • PAS phase through 5 years
All Adverse Events adjudicated by Clinical Events Committee
|
|
Ear and labyrinth disorders
Ear infection, both ears
|
2.0%
1/51 • Number of events 1 • PAS phase through 5 years
All Adverse Events adjudicated by Clinical Events Committee
|
|
Surgical and medical procedures
Eyelid lift; both eyes
|
2.0%
1/51 • Number of events 1 • PAS phase through 5 years
All Adverse Events adjudicated by Clinical Events Committee
|
|
Nervous system disorders
Headache
|
2.0%
1/51 • Number of events 1 • PAS phase through 5 years
All Adverse Events adjudicated by Clinical Events Committee
|
|
Cardiac disorders
High blood pressure
|
2.0%
1/51 • Number of events 1 • PAS phase through 5 years
All Adverse Events adjudicated by Clinical Events Committee
|
|
Ear and labyrinth disorders
Impacted cerumen, right ear
|
2.0%
1/51 • Number of events 1 • PAS phase through 5 years
All Adverse Events adjudicated by Clinical Events Committee
|
|
Blood and lymphatic system disorders
Low platelets
|
2.0%
1/51 • Number of events 1 • PAS phase through 5 years
All Adverse Events adjudicated by Clinical Events Committee
|
|
Injury, poisoning and procedural complications
Motor vehicle accident
|
2.0%
1/51 • Number of events 1 • PAS phase through 5 years
All Adverse Events adjudicated by Clinical Events Committee
|
|
Infections and infestations
Sinus infection
|
2.0%
1/51 • Number of events 1 • PAS phase through 5 years
All Adverse Events adjudicated by Clinical Events Committee
|
|
Infections and infestations
Sinus symptoms, cold
|
2.0%
1/51 • Number of events 1 • PAS phase through 5 years
All Adverse Events adjudicated by Clinical Events Committee
|
|
Infections and infestations
Strep throat, resolving
|
2.0%
1/51 • Number of events 1 • PAS phase through 5 years
All Adverse Events adjudicated by Clinical Events Committee
|
|
Ear and labyrinth disorders
Tympanic membrane hematoma
|
2.0%
1/51 • Number of events 1 • PAS phase through 5 years
All Adverse Events adjudicated by Clinical Events Committee
|
|
Infections and infestations
Upper respiratory tract infection
|
2.0%
1/51 • Number of events 1 • PAS phase through 5 years
All Adverse Events adjudicated by Clinical Events Committee
|
|
Musculoskeletal and connective tissue disorders
Arthritis, R shoulder
|
2.0%
1/51 • Number of events 1 • PAS phase through 5 years
All Adverse Events adjudicated by Clinical Events Committee
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.0%
1/51 • Number of events 1 • PAS phase through 5 years
All Adverse Events adjudicated by Clinical Events Committee
|
|
Eye disorders
Brown's syndrome
|
2.0%
1/51 • Number of events 1 • PAS phase through 5 years
All Adverse Events adjudicated by Clinical Events Committee
|
|
Eye disorders
Cataract surgery
|
2.0%
1/51 • Number of events 1 • PAS phase through 5 years
All Adverse Events adjudicated by Clinical Events Committee
|
|
Renal and urinary disorders
Enlarged prostate
|
2.0%
1/51 • Number of events 1 • PAS phase through 5 years
All Adverse Events adjudicated by Clinical Events Committee
|
|
Surgical and medical procedures
Knee replacement
|
2.0%
1/51 • Number of events 1 • PAS phase through 5 years
All Adverse Events adjudicated by Clinical Events Committee
|
|
Ear and labyrinth disorders
Loss of balance
|
2.0%
1/51 • Number of events 1 • PAS phase through 5 years
All Adverse Events adjudicated by Clinical Events Committee
|
|
Ear and labyrinth disorders
Otitis Externa
|
2.0%
1/51 • Number of events 1 • PAS phase through 5 years
All Adverse Events adjudicated by Clinical Events Committee
|
|
Infections and infestations
Sacroiliitis
|
2.0%
1/51 • Number of events 1 • PAS phase through 5 years
All Adverse Events adjudicated by Clinical Events Committee
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion, sinus disease
|
2.0%
1/51 • Number of events 1 • PAS phase through 5 years
All Adverse Events adjudicated by Clinical Events Committee
|
|
Cardiac disorders
TIA
|
2.0%
1/51 • Number of events 1 • PAS phase through 5 years
All Adverse Events adjudicated by Clinical Events Committee
|
|
Ear and labyrinth disorders
Increased tinnitus
|
2.0%
1/51 • Number of events 1 • PAS phase through 5 years
All Adverse Events adjudicated by Clinical Events Committee
|
|
Ear and labyrinth disorders
Vertigo vs. disequilibrium
|
2.0%
1/51 • Number of events 1 • PAS phase through 5 years
All Adverse Events adjudicated by Clinical Events Committee
|
|
Ear and labyrinth disorders
Pain
|
2.0%
1/51 • Number of events 1 • PAS phase through 5 years
All Adverse Events adjudicated by Clinical Events Committee
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60