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The purpose of this investigation is to expand FDA-approved labeling for MED-EL cochlear implants to include adults who have moderate to profound sensorineural hearing loss and obtain limited benefit from appropriately fit hearing aids.
Fifty (50) subjects, 18 years of age and older, will be implanted across the United States and Canada. Subjects with moderate to profound bilateral sensorineural hearing loss will be implanted with the MED-EL SYNCHRONY/SYNCHRONY PIN Cochlear Implant System. .
Limited benefit from amplification is defined by test scores of 60% correct or less in the ear to be implanted (70% or less in the nonimplanted ear) on monosyllabic words in quiet. Subjects will be followed for twelve (12) months post-activation of the SONNETEAS Audio Processor.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single-arm | Experimental | Single-arm, repeated-measures study design with all subjects receiving a MED-EL cochlear implant |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MED-EL SYNCHRONY/SYNCHRONY PIN Cochlear Implant System | Device | Subjects will be implanted with the MED-EL SYNCHRONY/SYNCHRONY PIN Cochlear Implant System with +FLEX28 or +FLEXSOFT electrode arrays. Subjects will be fit with the SONNETEAS (ear-level) and/or RONDO (single-unit) external audio processors. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Percent Correct on Word Recognition in Quiet in Implanted Ear | CNC (Consonant Nucleus Consonant) word scores will be calculated as percent correct at baseline and at 6 months post-activation and reported as mean percentage-point improvement at 6 months post-activation compared to baseline. | 6 months post-activation |
| Change in Percent Correct of Words Identified for Sentences in Noise in Implanted Ear | AzBio sentence recognition in noise scores will be calculated as percent correct of words in each sentence at baseline and at 6 months post-activation and reported as mean percentage-point improvement at 6 months post-activation compared to baseline. | 6 months post-activation |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Global Score on Patient-reported Outcomes in Everyday Listening Condition | APHAB (ABBREVIATED PROFILE OF HEARING AID BENEFIT) questionnaire will be used to assess subjective outcomes and reported as change in mean Global Score at 6 months post-activation compared to baseline. Letter responses from A to G on each question have a percent value, and the Global Score is an average percent value of all letters. A lower score shows less difficulty (better performance). |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami | Miami | Florida | 33136 | United States | ||
| University of North Carolina |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22090001 | Background | Amoodi HA, Mick PT, Shipp DB, Friesen LM, Nedzelski JM, Chen JM, Lin VY. Results with cochlear implantation in adults with speech recognition scores exceeding current criteria. Otol Neurotol. 2012 Jan;33(1):6-12. doi: 10.1097/MAO.0b013e318239e5a1. | |
| 16148696 | Background | Bassim MK, Buss E, Clark MS, Kolln KA, Pillsbury CH, Pillsbury HC 3rd, Buchman CA. MED-EL Combi40+ cochlear implantation in adults. Laryngoscope. 2005 Sep;115(9):1568-73. doi: 10.1097/01.mlg.0000171023.72680.95. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Single-arm | Single-arm, repeated-measures study design with all subjects receiving a MED-EL cochlear implant MED-EL SYNCHRONY/SYNCHRONY PIN Cochlear Implant System: Subjects will be implanted with the MED-EL SYNCHRONY/SYNCHRONY PIN Cochlear Implant System with +FLEX28 or +FLEXSOFT electrode arrays. Subjects will be fit with the SONNETEAS (ear-level) and/or RONDO (single-unit) external audio processors. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Single-arm | Single-arm, repeated-measures study design with all subjects receiving a MED-EL cochlear implant MED-EL SYNCHRONY/SYNCHRONY 2 (PIN) Cochlear Implant System: Subjects were implanted with the MED-EL SYNCHRONY/SYNCHRONY 2 (PIN) Cochlear Implant System with +FLEX28 or +FLEXSOFT electrode arrays. Subjects were fit with the SONNET/SONNET 2 EAS (ear-level) and/or RONDO/RONDO 2/RONDO 3 (single-unit) external audio processors. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Percent Correct on Word Recognition in Quiet in Implanted Ear | CNC (Consonant Nucleus Consonant) word scores will be calculated as percent correct at baseline and at 6 months post-activation and reported as mean percentage-point improvement at 6 months post-activation compared to baseline. | Analysis population includes participants in the intent-to-treat (implanted) population with 6-month data or imputed data for primary endpoint analysis. | Posted | Mean | Standard Deviation | Change in percentage points | 6 months post-activation |
|
Adverse device effects were collected through study completion for all participants. Timeframe for adverse event reporting ranged from 1 year, 4 months for the last implanted subject to 4 years, 10 months for the first implanted subject.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Single-arm | Single-arm, repeated-measures study design with all subjects receiving a MED-EL cochlear implant MED-EL SYNCHRONY/SYNCHRONY PIN Cochlear Implant System: Subjects will be implanted with the MED-EL SYNCHRONY/SYNCHRONY PIN Cochlear Implant System with +FLEX28 or +FLEXSOFT electrode arrays. Subjects will be fit with the SONNETEAS (ear-level) and/or RONDO (single-unit) external audio processors. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Loss of residual hearing | Ear and labyrinth disorders | Systematic Assessment | Loss of residual hearing after implantation |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Temporary loss of residual hearing | Ear and labyrinth disorders | Systematic Assessment | Temporary shift in hearing thresholds improving by the study endpoint |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Research Manager | MED-EL Corporation | 888-633-3524 | research.us@medel.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 20, 2020 | Nov 11, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006319 | Hearing Loss, Sensorineural |
| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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|
|
| 6 months post-activation |
| Number of Participants Experiencing an Adverse Device Effect (ADE) | Adverse device effects will be collected for all participants through study completion and reported as the number of participants experiencing an ADE. | Through study completion, or at least 1 year, 4 months post-implantation |
| Number of Participants With Residual Low-frequency Hearing | HEARRING scale will be used to calculate the percent of hearing preservation for each subject by comparing average hearing thresholds from 125 to 1000 Hz at 6 months post-activation to the average at baseline. | 6 months post-activation |
| Change in Overall Score on Patient-reported Outcomes in Everyday Listening Condition | The SSQ (Spatial and Qualities of Hearing) questionnaire will be used to assess subjective outcomes and reported as change in mean Overall Score at 6 months post-activation compared to baseline. SSQ is scored on a 10-point Likert scale where 10 shows better listening skills/experiences than 0. | 6 months post-activation |
| Chapel Hill |
| North Carolina |
| 27599 |
| United States |
| Vanderbilt University | Nashville | Tennessee | 37232 | United States |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| Sunnybrook Health Sciences Centre | Toronto | Ontario | M4N 3M5 | Canada |
| 7789669 | Background | Cox RM, Alexander GC. The abbreviated profile of hearing aid benefit. Ear Hear. 1995 Apr;16(2):176-86. doi: 10.1097/00003446-199504000-00005. |
| 15564849 | Background | Cullen RD, Higgins C, Buss E, Clark M, Pillsbury HC 3rd, Buchman CA. Cochlear implantation in patients with substantial residual hearing. Laryngoscope. 2004 Dec;114(12):2218-23. doi: 10.1097/01.mlg.0000149462.88327.7f. |
| 18057874 | Background | Dorman MF, Gifford RH, Spahr AJ, McKarns SA. The benefits of combining acoustic and electric stimulation for the recognition of speech, voice and melodies. Audiol Neurootol. 2008;13(2):105-12. doi: 10.1159/000111782. Epub 2007 Nov 29. |
| 17063013 | Background | Gantz BJ, Turner C, Gfeller KE. Acoustic plus electric speech processing: preliminary results of a multicenter clinical trial of the Iowa/Nucleus Hybrid implant. Audiol Neurootol. 2006;11 Suppl 1:63-8. doi: 10.1159/000095616. Epub 2006 Oct 6. |
| 15035561 | Background | Gatehouse S, Noble W. The Speech, Spatial and Qualities of Hearing Scale (SSQ). Int J Audiol. 2004 Feb;43(2):85-99. doi: 10.1080/14992020400050014. |
| 17675589 | Background | Gifford RH, Dorman MF, McKarns SA, Spahr AJ. Combined electric and contralateral acoustic hearing: word and sentence recognition with bimodal hearing. J Speech Lang Hear Res. 2007 Aug;50(4):835-43. doi: 10.1044/1092-4388(2007/058). |
| 20071994 | Background | Gifford RH, Dorman MF, Shallop JK, Sydlowski SA. Evidence for the expansion of adult cochlear implant candidacy. Ear Hear. 2010 Apr;31(2):186-94. doi: 10.1097/AUD.0b013e3181c6b831. |
| 23446225 | Background | Gifford RH, Dorman MF, Skarzynski H, Lorens A, Polak M, Driscoll CL, Roland P, Buchman CA. Cochlear implantation with hearing preservation yields significant benefit for speech recognition in complex listening environments. Ear Hear. 2013 Jul-Aug;34(4):413-25. doi: 10.1097/AUD.0b013e31827e8163. |
| 18212519 | Background | Gifford RH, Shallop JK, Peterson AM. Speech recognition materials and ceiling effects: considerations for cochlear implant programs. Audiol Neurootol. 2008;13(3):193-205. doi: 10.1159/000113510. Epub 2008 Jan 22. |
| 8132902 | Background | Nilsson M, Soli SD, Sullivan JA. Development of the Hearing in Noise Test for the measurement of speech reception thresholds in quiet and in noise. J Acoust Soc Am. 1994 Feb;95(2):1085-99. doi: 10.1121/1.408469. |
| 14485785 | Background | PETERSON GE, LEHISTE I. Revised CNC lists for auditory tests. J Speech Hear Disord. 1962 Feb;27:62-70. doi: 10.1044/jshd.2701.62. No abstract available. |
| 24328756 | Background | Skarzynski H, van de Heyning P, Agrawal S, Arauz SL, Atlas M, Baumgartner W, Caversaccio M, de Bodt M, Gavilan J, Godey B, Green K, Gstoettner W, Hagen R, Han DM, Kameswaran M, Karltorp E, Kompis M, Kuzovkov V, Lassaletta L, Levevre F, Li Y, Manikoth M, Martin J, Mlynski R, Mueller J, O'Driscoll M, Parnes L, Prentiss S, Pulibalathingal S, Raine CH, Rajan G, Rajeswaran R, Rivas JA, Rivas A, Skarzynski PH, Sprinzl G, Staecker H, Stephan K, Usami S, Yanov Y, Zernotti ME, Zimmermann K, Lorens A, Mertens G. Towards a consensus on a hearing preservation classification system. Acta Otolaryngol Suppl. 2013;(564):3-13. doi: 10.3109/00016489.2013.869059. |
| 21829134 | Background | Spahr AJ, Dorman MF, Litvak LM, Van Wie S, Gifford RH, Loizou PC, Loiselle LM, Oakes T, Cook S. Development and validation of the AzBio sentence lists. Ear Hear. 2012 Jan-Feb;33(1):112-7. doi: 10.1097/AUD.0b013e31822c2549. |
| 27099115 | Background | Verschuur C, Hellier W, Teo C. An evaluation of hearing preservation outcomes in routine cochlear implant care: Implications for candidacy. Cochlear Implants Int. 2016 Apr;17 Suppl 1:62-5. doi: 10.1080/14670100.2016.1152007. |
| 27099109 | Background | Vickers D, De Raeve L, Graham J. International survey of cochlear implant candidacy. Cochlear Implants Int. 2016 Apr;17 Suppl 1:36-41. doi: 10.1080/14670100.2016.1155809. |
| 21606646 | Background | von Ilberg CA, Baumann U, Kiefer J, Tillein J, Adunka OF. Electric-acoustic stimulation of the auditory system: a review of the first decade. Audiol Neurootol. 2011;16 Suppl 2:1-30. doi: 10.1159/000327765. Epub 2011 May 24. |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | Change in Percent Correct of Words Identified for Sentences in Noise in Implanted Ear | AzBio sentence recognition in noise scores will be calculated as percent correct of words in each sentence at baseline and at 6 months post-activation and reported as mean percentage-point improvement at 6 months post-activation compared to baseline. | Analysis population includes participants in the intent-to-treat (implanted) population with 6-month data or imputed data for primary endpoint analysis. | Posted | Mean | Standard Deviation | Change in percentage points | 6 months post-activation |
|
|
|
| Secondary | Change in Global Score on Patient-reported Outcomes in Everyday Listening Condition | APHAB (ABBREVIATED PROFILE OF HEARING AID BENEFIT) questionnaire will be used to assess subjective outcomes and reported as change in mean Global Score at 6 months post-activation compared to baseline. Letter responses from A to G on each question have a percent value, and the Global Score is an average percent value of all letters. A lower score shows less difficulty (better performance). | Analysis population includes participants in the intent-to-treat (implanted) population with 6-month data or imputed data for endpoint analysis. Note: not all participants completed the patient questionnaire. | Posted | Mean | Standard Deviation | Change in percent, listening difficulty | 6 months post-activation |
|
|
|
| Secondary | Number of Participants Experiencing an Adverse Device Effect (ADE) | Adverse device effects will be collected for all participants through study completion and reported as the number of participants experiencing an ADE. | Posted | Count of Participants | Participants | Through study completion, or at least 1 year, 4 months post-implantation |
|
|
|
| Secondary | Number of Participants With Residual Low-frequency Hearing | HEARRING scale will be used to calculate the percent of hearing preservation for each subject by comparing average hearing thresholds from 125 to 1000 Hz at 6 months post-activation to the average at baseline. | Analysis population includes participants in the intent-to-treat (implanted) population with 6-month data or imputed data for endpoint analysis. | Posted | Count of Participants | Participants | 6 months post-activation |
|
|
|
| Secondary | Change in Overall Score on Patient-reported Outcomes in Everyday Listening Condition | The SSQ (Spatial and Qualities of Hearing) questionnaire will be used to assess subjective outcomes and reported as change in mean Overall Score at 6 months post-activation compared to baseline. SSQ is scored on a 10-point Likert scale where 10 shows better listening skills/experiences than 0. | Analysis population includes participants in the intent-to-treat (implanted) population with 6-month data or imputed data for endpoint analysis. Note: not all participants completed the patient questionnaire. | Posted | Mean | Standard Deviation | Units on a scale | 6 months post-activation |
|
|
|
| 0 |
| 44 |
| 21 |
| 44 |
| 10 |
| 44 |
|
| Vertigo | Ear and labyrinth disorders | Non-systematic Assessment | Hospitalization for vertigo |
|
|
| Dizziness, imbalance, vertigo | Ear and labyrinth disorders | Non-systematic Assessment |
|
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| D012678 |
| Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| No Hearing Preservation |
|