The French Cochlear Implant Registry (EPIIC): Cochlear implant candidacy assessment of off-label indications
Evaluate in France the outcomes of cochlear implantation outside the selection criteria, off-label. This is a prospective cohort study including adults and children having received a cochlear implant (CI) in an off-label indication, that is outside the criteria established by the “Haute Autorité de...
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| creator | Quatre, R. Fabre, C. Aubry, K. Bordure, P. Bozorg-Grayeli, A. Deguine, O. Eyermann, C. Franco-Vidal, V. Godey, B. Guevara, N. Karkas, A. Klopp, N. Labrousse, M. Lebreton, J.-P. Lerosey, Y. Lescanne, E. Loundon, N. Marianowski, R. Merklen, F. Mezouaghi, K. Mom, T. Moreau, S. Mosnier, I. Noël-Petroff, N. Parietti-Winkler, C. Piller, P. Poncet, C. Radafy, E. Roman, S. Roux-Vaillard, S. Tavernier, L. Truy, E. Vincent, C. Schmerber, S. |
| description | Evaluate in France the outcomes of cochlear implantation outside the selection criteria, off-label.
This is a prospective cohort study including adults and children having received a cochlear implant (CI) in an off-label indication, that is outside the criteria established by the “Haute Autorité de santé (HAS)” in 2012. The data was collected from the “EPIIC” registry on recipients who received CIs in France between 2011 and 2014. Speech audiometry was performed at 60dB preimplantation and after one year of CI use, as well as an evaluation of the scores of the quality of life with the APHAB questionnaire, the scores for CAP and the professional/academic status in pre- and post-implantation conditions. Major and minor complications at surgery have been recorded.
In total, 590 patients (447 adults and 143 children) with an off-label indication for CIs were included in this study from the EPIIC registry (11.7% of the whole cohort of EPIIC). For adults, the median percentage of comprehension using monosyllabic word lists was 41% in preimplantation condition versus 53% after one year of CI use (P |
| doi_str_mv | 10.1016/j.anorl.2020.07.012 |
| format | Article |
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This is a prospective cohort study including adults and children having received a cochlear implant (CI) in an off-label indication, that is outside the criteria established by the “Haute Autorité de santé (HAS)” in 2012. The data was collected from the “EPIIC” registry on recipients who received CIs in France between 2011 and 2014. Speech audiometry was performed at 60dB preimplantation and after one year of CI use, as well as an evaluation of the scores of the quality of life with the APHAB questionnaire, the scores for CAP and the professional/academic status in pre- and post-implantation conditions. Major and minor complications at surgery have been recorded.
In total, 590 patients (447 adults and 143 children) with an off-label indication for CIs were included in this study from the EPIIC registry (11.7% of the whole cohort of EPIIC). For adults, the median percentage of comprehension using monosyllabic word lists was 41% in preimplantation condition versus 53% after one year of CI use (P<0.001) and 60% versus 71% in dissyllabic word lists (P<0.001). The CAP scores were 5 versus 6 in pre- and post-implantation conditions respectively (P<0.001) and the APHAB scores were statistically lower after implantation (P<0.001). In the children cohort, the median percentage of comprehension using monosyllabic word lists was 51% in preimplantation condition and 65% after CI (P<0.001), and 48% versus 82% (P<0.001) for dissyllabic word lists. The CAP scores were 5 versus 7 respectively in pre- and post-CI conditions (P<0.001). Thirty-two minor complications (5.4%) and 17 major complications (2.8%) were reported in our panel of off-label indication patients.
These results suggest that a revision of the cochlear implantation candidacy criteria is necessary to allow more patients with severe or asymmetric hearing loss to benefit from a CI when there is an impact on quality of life despite the use of an optimal hearing aid.]]></description><identifier>ISSN: 1879-7296</identifier><identifier>EISSN: 1879-730X</identifier><identifier>DOI: 10.1016/j.anorl.2020.07.012</identifier><language>eng</language><publisher>Elsevier Masson SAS</publisher><subject>Biological Physics ; Hearing in noise ; Indications ; Off-label indication ; Outside the selection criteria ; Partial deafness ; Physics ; Revision ; Sensorineural deafness ; Single-sided deafness ; Speech audiometry</subject><ispartof>European annals of otorhinolaryngology, head and neck diseases, 2020-09, Vol.137, p.S27-S35</ispartof><rights>2020 Elsevier Masson SAS</rights><rights>Attribution - NonCommercial</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c415t-23b698525b7cee75858f9761132b74e33ab4eb1107940c389b232990c08b4923</citedby><cites>FETCH-LOGICAL-c415t-23b698525b7cee75858f9761132b74e33ab4eb1107940c389b232990c08b4923</cites><orcidid>0000-0002-4286-6465 ; 0000-0002-1769-8623 ; 0000-0002-4353-9431 ; 0000-0002-4279-8095</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.sciencedirect.com/science/article/pii/S1879729620301782$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>230,314,776,780,881,3536,27903,27904,65309</link.rule.ids><backlink>$$Uhttps://hal.science/hal-03610671$$DView record in HAL$$Hfree_for_read</backlink></links><search><creatorcontrib>Quatre, R.</creatorcontrib><creatorcontrib>Fabre, C.</creatorcontrib><creatorcontrib>Aubry, K.</creatorcontrib><creatorcontrib>Bordure, P.</creatorcontrib><creatorcontrib>Bozorg-Grayeli, A.</creatorcontrib><creatorcontrib>Deguine, O.</creatorcontrib><creatorcontrib>Eyermann, C.</creatorcontrib><creatorcontrib>Franco-Vidal, V.</creatorcontrib><creatorcontrib>Godey, B.</creatorcontrib><creatorcontrib>Guevara, N.</creatorcontrib><creatorcontrib>Karkas, A.</creatorcontrib><creatorcontrib>Klopp, N.</creatorcontrib><creatorcontrib>Labrousse, M.</creatorcontrib><creatorcontrib>Lebreton, J.-P.</creatorcontrib><creatorcontrib>Lerosey, Y.</creatorcontrib><creatorcontrib>Lescanne, E.</creatorcontrib><creatorcontrib>Loundon, N.</creatorcontrib><creatorcontrib>Marianowski, R.</creatorcontrib><creatorcontrib>Merklen, F.</creatorcontrib><creatorcontrib>Mezouaghi, K.</creatorcontrib><creatorcontrib>Mom, T.</creatorcontrib><creatorcontrib>Moreau, S.</creatorcontrib><creatorcontrib>Mosnier, I.</creatorcontrib><creatorcontrib>Noël-Petroff, N.</creatorcontrib><creatorcontrib>Parietti-Winkler, C.</creatorcontrib><creatorcontrib>Piller, P.</creatorcontrib><creatorcontrib>Poncet, C.</creatorcontrib><creatorcontrib>Radafy, E.</creatorcontrib><creatorcontrib>Roman, S.</creatorcontrib><creatorcontrib>Roux-Vaillard, S.</creatorcontrib><creatorcontrib>Tavernier, L.</creatorcontrib><creatorcontrib>Truy, E.</creatorcontrib><creatorcontrib>Vincent, C.</creatorcontrib><creatorcontrib>Schmerber, S.</creatorcontrib><title>The French Cochlear Implant Registry (EPIIC): Cochlear implant candidacy assessment of off-label indications</title><title>European annals of otorhinolaryngology, head and neck diseases</title><description><![CDATA[Evaluate in France the outcomes of cochlear implantation outside the selection criteria, off-label.
This is a prospective cohort study including adults and children having received a cochlear implant (CI) in an off-label indication, that is outside the criteria established by the “Haute Autorité de santé (HAS)” in 2012. The data was collected from the “EPIIC” registry on recipients who received CIs in France between 2011 and 2014. Speech audiometry was performed at 60dB preimplantation and after one year of CI use, as well as an evaluation of the scores of the quality of life with the APHAB questionnaire, the scores for CAP and the professional/academic status in pre- and post-implantation conditions. Major and minor complications at surgery have been recorded.
In total, 590 patients (447 adults and 143 children) with an off-label indication for CIs were included in this study from the EPIIC registry (11.7% of the whole cohort of EPIIC). For adults, the median percentage of comprehension using monosyllabic word lists was 41% in preimplantation condition versus 53% after one year of CI use (P<0.001) and 60% versus 71% in dissyllabic word lists (P<0.001). The CAP scores were 5 versus 6 in pre- and post-implantation conditions respectively (P<0.001) and the APHAB scores were statistically lower after implantation (P<0.001). In the children cohort, the median percentage of comprehension using monosyllabic word lists was 51% in preimplantation condition and 65% after CI (P<0.001), and 48% versus 82% (P<0.001) for dissyllabic word lists. The CAP scores were 5 versus 7 respectively in pre- and post-CI conditions (P<0.001). Thirty-two minor complications (5.4%) and 17 major complications (2.8%) were reported in our panel of off-label indication patients.
These results suggest that a revision of the cochlear implantation candidacy criteria is necessary to allow more patients with severe or asymmetric hearing loss to benefit from a CI when there is an impact on quality of life despite the use of an optimal hearing aid.]]></description><subject>Biological Physics</subject><subject>Hearing in noise</subject><subject>Indications</subject><subject>Off-label indication</subject><subject>Outside the selection criteria</subject><subject>Partial deafness</subject><subject>Physics</subject><subject>Revision</subject><subject>Sensorineural deafness</subject><subject>Single-sided deafness</subject><subject>Speech audiometry</subject><issn>1879-7296</issn><issn>1879-730X</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2020</creationdate><recordtype>article</recordtype><recordid>eNp9kU1LAzEQhhdRUNRf4GWP7WHXSbK7SQQPUvwoFBTpwVvIprM2Jd3UZBX6702tHzeHwAzD874webPsgkBJgDSXq1L3PriSAoUSeAmEHmQnRHBZcAYvhz8zlc1xdh7jClIxISTIk8zNl5jfBezNMp94s3SoQz5db5zuh_wZX20cwjYf3T5Np5Px1R9ivxGj-4VdaLPNdYwY4xrT0nfpdYXTLbrcJsDowfo-nmVHnXYRz7_7aTa_u51PHorZ4_10cjMrTEXqoaCsbaSoad1yg8hrUYtO8oYQRlteIWO6rbAlBLiswDAhW8qolGBAtJWk7DQb722X2qlNsGsdtsprqx5uZmq3A9YQaDj5IIkd7dlN8G_vGAe1ttGgS8ehf4-KVowISijd2bI9aoKPMWD3601A7ZJQK_WVhNoloYCrlERSXe9VmA7-sBhUNDZ9Ny5sQDOohbf_6j8ByySQWQ</recordid><startdate>202009</startdate><enddate>202009</enddate><creator>Quatre, R.</creator><creator>Fabre, C.</creator><creator>Aubry, K.</creator><creator>Bordure, P.</creator><creator>Bozorg-Grayeli, A.</creator><creator>Deguine, O.</creator><creator>Eyermann, C.</creator><creator>Franco-Vidal, V.</creator><creator>Godey, B.</creator><creator>Guevara, N.</creator><creator>Karkas, A.</creator><creator>Klopp, N.</creator><creator>Labrousse, M.</creator><creator>Lebreton, J.-P.</creator><creator>Lerosey, Y.</creator><creator>Lescanne, E.</creator><creator>Loundon, N.</creator><creator>Marianowski, R.</creator><creator>Merklen, F.</creator><creator>Mezouaghi, K.</creator><creator>Mom, T.</creator><creator>Moreau, S.</creator><creator>Mosnier, I.</creator><creator>Noël-Petroff, N.</creator><creator>Parietti-Winkler, C.</creator><creator>Piller, P.</creator><creator>Poncet, C.</creator><creator>Radafy, E.</creator><creator>Roman, S.</creator><creator>Roux-Vaillard, S.</creator><creator>Tavernier, L.</creator><creator>Truy, E.</creator><creator>Vincent, C.</creator><creator>Schmerber, S.</creator><general>Elsevier Masson SAS</general><general>Elsevier Masson</general><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope><scope>1XC</scope><scope>VOOES</scope><orcidid>https://orcid.org/0000-0002-4286-6465</orcidid><orcidid>https://orcid.org/0000-0002-1769-8623</orcidid><orcidid>https://orcid.org/0000-0002-4353-9431</orcidid><orcidid>https://orcid.org/0000-0002-4279-8095</orcidid></search><sort><creationdate>202009</creationdate><title>The French Cochlear Implant Registry (EPIIC): Cochlear implant candidacy assessment of off-label indications</title><author>Quatre, R. ; Fabre, C. ; Aubry, K. ; Bordure, P. ; Bozorg-Grayeli, A. ; Deguine, O. ; Eyermann, C. ; Franco-Vidal, V. ; Godey, B. ; Guevara, N. ; Karkas, A. ; Klopp, N. ; Labrousse, M. ; Lebreton, J.-P. ; Lerosey, Y. ; Lescanne, E. ; Loundon, N. ; Marianowski, R. ; Merklen, F. ; Mezouaghi, K. ; Mom, T. ; Moreau, S. ; Mosnier, I. ; Noël-Petroff, N. ; Parietti-Winkler, C. ; Piller, P. ; Poncet, C. ; Radafy, E. ; Roman, S. ; Roux-Vaillard, S. ; Tavernier, L. ; Truy, E. ; Vincent, C. ; Schmerber, S.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c415t-23b698525b7cee75858f9761132b74e33ab4eb1107940c389b232990c08b4923</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2020</creationdate><topic>Biological Physics</topic><topic>Hearing in noise</topic><topic>Indications</topic><topic>Off-label indication</topic><topic>Outside the selection criteria</topic><topic>Partial deafness</topic><topic>Physics</topic><topic>Revision</topic><topic>Sensorineural deafness</topic><topic>Single-sided deafness</topic><topic>Speech audiometry</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Quatre, R.</creatorcontrib><creatorcontrib>Fabre, C.</creatorcontrib><creatorcontrib>Aubry, K.</creatorcontrib><creatorcontrib>Bordure, P.</creatorcontrib><creatorcontrib>Bozorg-Grayeli, A.</creatorcontrib><creatorcontrib>Deguine, O.</creatorcontrib><creatorcontrib>Eyermann, C.</creatorcontrib><creatorcontrib>Franco-Vidal, V.</creatorcontrib><creatorcontrib>Godey, B.</creatorcontrib><creatorcontrib>Guevara, N.</creatorcontrib><creatorcontrib>Karkas, A.</creatorcontrib><creatorcontrib>Klopp, N.</creatorcontrib><creatorcontrib>Labrousse, M.</creatorcontrib><creatorcontrib>Lebreton, J.-P.</creatorcontrib><creatorcontrib>Lerosey, Y.</creatorcontrib><creatorcontrib>Lescanne, E.</creatorcontrib><creatorcontrib>Loundon, N.</creatorcontrib><creatorcontrib>Marianowski, R.</creatorcontrib><creatorcontrib>Merklen, F.</creatorcontrib><creatorcontrib>Mezouaghi, K.</creatorcontrib><creatorcontrib>Mom, T.</creatorcontrib><creatorcontrib>Moreau, S.</creatorcontrib><creatorcontrib>Mosnier, I.</creatorcontrib><creatorcontrib>Noël-Petroff, N.</creatorcontrib><creatorcontrib>Parietti-Winkler, C.</creatorcontrib><creatorcontrib>Piller, P.</creatorcontrib><creatorcontrib>Poncet, C.</creatorcontrib><creatorcontrib>Radafy, E.</creatorcontrib><creatorcontrib>Roman, S.</creatorcontrib><creatorcontrib>Roux-Vaillard, S.</creatorcontrib><creatorcontrib>Tavernier, L.</creatorcontrib><creatorcontrib>Truy, E.</creatorcontrib><creatorcontrib>Vincent, C.</creatorcontrib><creatorcontrib>Schmerber, S.</creatorcontrib><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><collection>Hyper Article en Ligne (HAL)</collection><collection>Hyper Article en Ligne (HAL) (Open Access)</collection><jtitle>European annals of otorhinolaryngology, head and neck diseases</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Quatre, R.</au><au>Fabre, C.</au><au>Aubry, K.</au><au>Bordure, P.</au><au>Bozorg-Grayeli, A.</au><au>Deguine, O.</au><au>Eyermann, C.</au><au>Franco-Vidal, V.</au><au>Godey, B.</au><au>Guevara, N.</au><au>Karkas, A.</au><au>Klopp, N.</au><au>Labrousse, M.</au><au>Lebreton, J.-P.</au><au>Lerosey, Y.</au><au>Lescanne, E.</au><au>Loundon, N.</au><au>Marianowski, R.</au><au>Merklen, F.</au><au>Mezouaghi, K.</au><au>Mom, T.</au><au>Moreau, S.</au><au>Mosnier, I.</au><au>Noël-Petroff, N.</au><au>Parietti-Winkler, C.</au><au>Piller, P.</au><au>Poncet, C.</au><au>Radafy, E.</au><au>Roman, S.</au><au>Roux-Vaillard, S.</au><au>Tavernier, L.</au><au>Truy, E.</au><au>Vincent, C.</au><au>Schmerber, S.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>The French Cochlear Implant Registry (EPIIC): Cochlear implant candidacy assessment of off-label indications</atitle><jtitle>European annals of otorhinolaryngology, head and neck diseases</jtitle><date>2020-09</date><risdate>2020</risdate><volume>137</volume><spage>S27</spage><epage>S35</epage><pages>S27-S35</pages><issn>1879-7296</issn><eissn>1879-730X</eissn><abstract><![CDATA[Evaluate in France the outcomes of cochlear implantation outside the selection criteria, off-label.
This is a prospective cohort study including adults and children having received a cochlear implant (CI) in an off-label indication, that is outside the criteria established by the “Haute Autorité de santé (HAS)” in 2012. The data was collected from the “EPIIC” registry on recipients who received CIs in France between 2011 and 2014. Speech audiometry was performed at 60dB preimplantation and after one year of CI use, as well as an evaluation of the scores of the quality of life with the APHAB questionnaire, the scores for CAP and the professional/academic status in pre- and post-implantation conditions. Major and minor complications at surgery have been recorded.
In total, 590 patients (447 adults and 143 children) with an off-label indication for CIs were included in this study from the EPIIC registry (11.7% of the whole cohort of EPIIC). For adults, the median percentage of comprehension using monosyllabic word lists was 41% in preimplantation condition versus 53% after one year of CI use (P<0.001) and 60% versus 71% in dissyllabic word lists (P<0.001). The CAP scores were 5 versus 6 in pre- and post-implantation conditions respectively (P<0.001) and the APHAB scores were statistically lower after implantation (P<0.001). In the children cohort, the median percentage of comprehension using monosyllabic word lists was 51% in preimplantation condition and 65% after CI (P<0.001), and 48% versus 82% (P<0.001) for dissyllabic word lists. The CAP scores were 5 versus 7 respectively in pre- and post-CI conditions (P<0.001). Thirty-two minor complications (5.4%) and 17 major complications (2.8%) were reported in our panel of off-label indication patients.
These results suggest that a revision of the cochlear implantation candidacy criteria is necessary to allow more patients with severe or asymmetric hearing loss to benefit from a CI when there is an impact on quality of life despite the use of an optimal hearing aid.]]></abstract><pub>Elsevier Masson SAS</pub><doi>10.1016/j.anorl.2020.07.012</doi><orcidid>https://orcid.org/0000-0002-4286-6465</orcidid><orcidid>https://orcid.org/0000-0002-1769-8623</orcidid><orcidid>https://orcid.org/0000-0002-4353-9431</orcidid><orcidid>https://orcid.org/0000-0002-4279-8095</orcidid><oa>free_for_read</oa></addata></record> |
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| source | Elsevier ScienceDirect Journals; EZB-FREE-00999 freely available EZB journals |
| subjects | Biological Physics Hearing in noise Indications Off-label indication Outside the selection criteria Partial deafness Physics Revision Sensorineural deafness Single-sided deafness Speech audiometry |
| title | The French Cochlear Implant Registry (EPIIC): Cochlear implant candidacy assessment of off-label indications |
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