Hearing Loss
Conditions
Keywords
hearing loss, sensorineural, hearing implant
Brief summary
The purpose of this study is to evaluate the long-term safety and efficacy of the Esteem® Hearing Implant in subjects suffering from moderate to severe hearing loss.
Detailed description
The Post Approval Study is an extension of the pivotal clinical trial, which was designed as a prospective, multi-center, non-randomized, clinical trial to evaluate the safety and efficacy of the Esteem® System. For this trial the subject acts as his or her own control. This trial has been designed to meet the United States' regulatory requirements. The subjects included in this study include the 57 subjects implanted under the original Investigational Device Exemption (IDE) study and the five (5) subjects implanted under the continued access expansion approved by the FDA. Of these 62 subjects, all but one (explant) were available for continued follow-up. These subjects were re-consented for the 5 year Post Approval Study. No new subjects were enrolled and implanted in this study. The goal was to monitor a minimum of 45 subjects through their five (5) year follow-up. Ultimately, 51 subjects completed the study. The following questions are to be answered: * Is the Esteem effective through 5 year follow-up? * Is the Esteem safe through 5 year follow-up?
Interventions
DEVICEThe Esteem Hearing Implant
The Esteem® Hearing Implant is designed to improve hearing in subjects suffering from moderate to severe hearing loss that is sensorineural in origin. The Esteem® has been approved by FDA for the US market under Pre-Market Approval P090018 and this study fulfills the requirement for one of the Post Approval Studies.
Sponsors
Envoy Medical Corporation
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
Yes
Inclusion criteria
Subject must meet all of the following criteria to be eligible for treatment in the trial: 1. Subject is at least 18 years old 2. Subject understands the nature of the procedure and has signed the Subject Informed Consent Form prior to the procedure 3. Subject is willing and able to comply with specified follow-up evaluations and understands the audiological test procedures and use of the Esteem® System. 4. Subject has moderate to severe sensorineural hearing loss between 500 and 4000 Hz in the ear to be implanted with pure tone air-conduction threshold levels within the limits of a Hearing Aid (HA) as follow: Freq (Hz) 500 1000 2000 3000 4000 Lower Level (dB HL) 30 35 35 35 35 Upper Level (dB HL) 100 100 100 100 100 5. Subject's air-bone gap is no greater than 10 dB at 4 of the 5 following frequencies: 500, 1000, 2000, 3000 and 4000 Hz. 6. Subject has an unaided maximum word recognition score of greater than or equal to 40% with recorded delivery using a phonetically balanced word list at Speech Reception Threshold (SRT) + 40 dB or at maximum tolerable presentation level. 7. Subject is a current user of a properly functioning and appropriately fit hearing aid. This is defined as the subject has used this aid for at least four (4) hours (average) per day (in the ear to be implanted) for at least three (3) months for a new aid or one (1) month for an adjusted aid. 8. Subject's hearing aid, in the ear to be implanted, shall appropriately fit optimally. 9. Subject has normally functioning eustachian tube 10. Subject has normal tympanic membrane 11. Subject has a normal middle ear anatomy 12. Subject has adequate space for Esteem® System implant determined via fine cut temporal bone CT scan 13. Subject is a native speaker of the English language. 14. Subject is a hearing aid user in the ear to be implanted
Exclusion criteria
Subjects will be excluded from the trial if any one of the following criteria is met: 1. Subject has a history of post-adolescent chronic middle ear infections, inner ear disorders or recurring vertigo requiring treatment, disorders such as mastoiditis, Hydrops or Meniere's syndrome or disease 2. Subject has a history of external otitis or eczema for the outer ear canal and the investigator believes this will affect the Esteem® System implantation 3. Subject has cholesteatoma or destructive middle ear disease 4. Subject has life expectancy of less than two (2) years due to other medical conditions 5. Subject has retrocochlear or central auditory disorders 6. Subject is known to be suffering from any psychological, developmental, physical, or emotional disorder that the investigator feels would interfere with the surgery or follow-up testing 7. Subject has a known history of fluctuating air conduction and/or bone conduction hearing loss over a one-year period of 15 dB in either direction at 2 or more frequencies (from 500 - 4000 Hz) 8. Subject has sudden hearing loss due to unknown cause 9. Subject has a history of disabling tinnitus, defined as tinnitus which required treatment. 10. Subject is unable to adequately perform audiological testing 11. Subject has a medical condition or undergoing a treatment that may affect healing and the investigator does not believe the subject is a good candidate for the trial. 12. Subject has diabetes that is not well controlled with medication or diet and the investigator does not believe in his best medical judgment that the subject would be a good candidate for the trial 13. Subject is pregnant at the time of device implant 14. Subject has a history of keloid formation 15. Subject has known hypersensitivity to silicone rubber, polyurethane, stainless steel, titanium and/or gold
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline (Pre-implant Aided Condition) at Year 5 in Speech Reception Threshold (SRT) | Baseline through Year 5 of 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. |
| Change From Baseline (Pre-implant Aided Condition) at Year 5 in Word Recognition Score (WRS) at 50 dB HL | Baseline through Year 5 of Follow Up | ENDPOINT #2: WRS at Year 5 minus WRS at baseline. Positive difference (in % correct) indicates better outcome. |
| Incidence of Serious Adverse Device Events (SADEs) and Device Failures and Replacements at Each Follow-up. | SADEs, PAS phase through Year 5 of Follow Up | ENDPOINT #3: The analysis of the incidence of SADEs and device failures and replacements at each follow-up. |
| Bone Conduction Stability | Baseline through 5 Year Follow-Up | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in Quality of Life as Reflected by Abbreviated Profile of Hearing Aid Benefit (APHAB) Questionnaire | Baseline through Year 5 of 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Esteem Implant Subjects implanted with the Esteem Totally Implantable Hearing System | 51 |
| Total | 51 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 2 |
Baseline characteristics
| Characteristic | Esteem Implant |
|---|---|
| Age, Continuous | 56.1 years STANDARD_DEVIATION 15.6 |
| Race/Ethnicity, Customized Asian | 1 participants |
| Race/Ethnicity, Customized Black/Non-Hispanic | 0 participants |
| Race/Ethnicity, Customized Hispanic | 0 participants |
| Race/Ethnicity, Customized White/Caucasian | 50 participants |
| Sex: Female, Male Female | 17 Participants |
| Sex: Female, Male Male | 34 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 42 / 51 |
| serious Total, serious adverse events | 14 / 51 |
Outcome results
Primary
Bone Conduction Stability
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.
Time frame: Baseline through 5 Year Follow-Up
Population: Difference between Baseline and 5 Year PTA (average of 500, 1000, 2000 Hz thresholds)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Esteem Implant | Bone Conduction Stability | 3.7 dB | Standard Error 1.1 |
Primary
Change From Baseline (Pre-implant Aided Condition) at Year 5 in Speech Reception Threshold (SRT)
ENDPOINT #1: SRT at baseline minus SRT at Year 5. Positive difference (i.e. lower value of SRT with the Esteem) indicates better outcome.
Time frame: Baseline through Year 5 of Follow Up
Population: 5 Year Follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Esteem Implant | Change From Baseline (Pre-implant Aided Condition) at Year 5 in Speech Reception Threshold (SRT) | 4.8 dB | Standard Error 2 |
Primary
Change From Baseline (Pre-implant Aided Condition) at Year 5 in Word Recognition Score (WRS) at 50 dB HL
ENDPOINT #2: WRS at Year 5 minus WRS at baseline. Positive difference (in % correct) indicates better outcome.
Time frame: Baseline through Year 5 of Follow Up
Population: 5 Year Follow-up Visit
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Esteem Implant | 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
Incidence of Serious Adverse Device Events (SADEs) and Device Failures and Replacements at Each Follow-up.
ENDPOINT #3: The analysis of the incidence of SADEs and device failures and replacements at each follow-up.
Time frame: SADEs, PAS phase through Year 5 of Follow Up
Population: Cumulative through 5-Year Follow-up
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Esteem Implant | Incidence of Serious Adverse Device Events (SADEs) and Device Failures and Replacements at Each Follow-up. | 3 participants |
Secondary
Improvement in Quality of Life as Reflected by Abbreviated Profile of Hearing Aid Benefit (APHAB) Questionnaire
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.
Time frame: Baseline through Year 5 of Follow Up
Population: 5 Year Follow-up
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Esteem Implant | 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 |