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This study will address the feasibility of simultaneous cochlear implantation during resection of a vestibular schwannoma.
This is prospective study patients undergoing a translabyrinthine resection for a vestibular schwannoma with intact hearing in the contralateral ear. During surgery, simultaneous cochlear implantation will be performed if the cochlear nerve can be identified and preserved during the resection.
Relevant data to be collected will include patient demographics, details related to the vestibular schwannoma including side, size, symptoms (specifically pre-operative hearing loss, degree of tinnitus), and status of hearing in the contralateral ear. Surgical details to be recorded will include date of surgery, surgical time, and whether the cochlear nerve was identified and preserved. Details related to the post-operative course to be recorded include length of stay in the hospital, post-operative complications such as wound infection or cerebral spinal fluid (CSF) leak, and need for revision or additional procedures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cochlear implantation | Experimental | Simultaneous cochlear implantation with tumor resection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cochlear implant | Device | Tumor resection with cochlear implant |
|
| Measure | Description | Time Frame |
|---|---|---|
| Measurement of Hearing Parameters | Audiologist assesses changes in understanding of the AzBio test (words in quiet and words in background noise) post cochlear implantation. | 1 month, 3 months and 6 months postoperatively. |
| Measurement of Hearing Parameters | Audiologist assesses changes in understanding of 50 random consonant-nucleus-consonant sounds. | 1 month, 3 months and 6 months postoperatively. |
| Measurement of Hearing Parameters | Audiologist assesses changes in understanding changes in understanding of Speech, Spatial and Qualities of Hearing. | 1 month, 3 months and 6 months postoperatively. |
| Measure | Description | Time Frame |
|---|---|---|
| Measurement of Change of Physical Symptoms Associated with Hearing Loss | Patients will complete the Dizziness Handicap Inventory | 1, 3 and 6 months postoperatively |
| Assessment of Change of Physical Symptoms Associated with Hearing Loss |
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Inclusion Criteria:
Exclusion Criteria:
-
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| Name | Affiliation | Role |
|---|---|---|
| Seilish Babu, MD | Michigan Ear Institute, Farmington Hills, MI | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seilesh Babu | Farmington Hills | Michigan | 48334 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29490548 | Background | Dos Santos Neto PH, Zamponi JO, Hamerschmidt R, Wiemes GRM, Rassi MS, Borba LAB. Simultaneous cochlear implantation as a therapeutic option in vestibular schwannoma surgery: case report. Neurosurg Focus. 2018 Mar;44(3):E9. doi: 10.3171/2017.12.FOCUS17670. | |
| 24335931 | Background | Lloyd SK, Glynn FJ, Rutherford SA, King AT, Mawman DJ, O'Driscoll MP, Evans DG, Ramsden RT, Freeman SR. Ipsilateral cochlear implantation after cochlear nerve preserving vestibular schwannoma surgery in patients with neurofibromatosis type 2. Otol Neurotol. 2014 Jan;35(1):43-51. doi: 10.1097/MAO.0000000000000185. |
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| ID | Term |
|---|---|
| D009464 | Neuroma, Acoustic |
| ID | Term |
|---|---|
| D009442 | Neurilemmoma |
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
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| ID | Term |
|---|---|
| D003054 | Cochlear Implants |
| ID | Term |
|---|---|
| D058117 | Neural Prostheses |
| D058542 | Implantable Neurostimulators |
| D004567 | Electrodes, Implanted |
| D004566 | Electrodes |
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Patients will complete the Tinnitus Handicap Inventory
| 1, 3 and 6 months postoperatively |
| Assessment of incision site healing | Surgeon evaluates wound hearing over 3 months | 1 week, and 1 and 3 months postoperatively |
| 28819872 | Background | Bohr C, Muller S, Hornung J, Hoppe U, Iro H. [Hearing restoration with cochlear implants after translabyrinthine vestibular schwannoma resection]. HNO. 2017 Sep;65(9):758-765. doi: 10.1007/s00106-017-0404-2. German. |
| 26498948 | Background | Hassepass F, Arndt S, Aschendorff A, Laszig R, Wesarg T. Cochlear implantation for hearing rehabilitation in single-sided deafness after translabyrinthine vestibular schwannoma surgery. Eur Arch Otorhinolaryngol. 2016 Sep;273(9):2373-83. doi: 10.1007/s00405-015-3801-8. Epub 2015 Oct 23. |
| 28602150 | Background | DeHart AN, Broaddus WC, Coelho DH. Translabyrinthine vestibular schwannoma resection with simultaneous cochlear implantation. Cochlear Implants Int. 2017 Sep;18(5):278-284. doi: 10.1080/14670100.2017.1337665. Epub 2017 Jun 12. |
| 27816972 | Background | Sanna M, Medina MD, Macak A, Rossi G, Sozzi V, Prasad SC. Vestibular Schwannoma Resection with Ipsilateral Simultaneous Cochlear Implantation in Patients with Normal Contralateral Hearing. Audiol Neurootol. 2016;21(5):286-295. doi: 10.1159/000448583. Epub 2016 Nov 5. |
| 29099442 | Background | Rooth MA, Dillon MT, Brown KD. Prospective Evaluation of Patients Undergoing Translabyrinthine Excision of Vestibular Schwannoma with Concurrent Cochlear Implantation. Otol Neurotol. 2017 Dec;38(10):1512-1516. doi: 10.1097/MAO.0000000000001570. |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009463 | Neuroma |
| D018317 | Nerve Sheath Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D003390 | Cranial Nerve Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D010524 | Peripheral Nervous System Neoplasms |
| D000160 | Vestibulocochlear Nerve Diseases |
| D012181 | Retrocochlear Diseases |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D010039 | Otorhinolaryngologic Neoplasms |
| D003389 | Cranial Nerve Diseases |
| D009422 | Nervous System Diseases |
| D055615 |
| Electrical Equipment and Supplies |
| D004864 | Equipment and Supplies |
| D019736 | Prostheses and Implants |
| D006310 | Hearing Aids |
| D012682 | Sensory Aids |