This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
Approval for the optional acoustic component amplifies low frequency sound, and sends it into the ear canal. The acoustic component is intended to provide access to these low frequency sounds for some cochlear nucleus implant recipients. The acoustic component is indicated for recipients of traditional cochlear nucleus implants with unaided air conduction thresholds less than or equal to 85 db hl between 125 hz and 2000 hz following surgery. The acoustic component should only be used when behavioural audiometric thresholds can be obtained and the recipient can provide feedback regarding sound quality. Speech perception testing should be completed before and after fitting with the acoustic component to ensure that the recipient performs as well, if not better, with the acoustic component than without it.
| Device | NUCLEUS COCHLEAR IMPLANT SYSTEM |
| Classification Name | Implant, Cochlear |
| Generic Name | Implant, Cochlear |
| Applicant | Cochlear Americas |
| Date Received | 2015-12-23 |
| Decision Date | 2016-06-20 |
| PMA | P970051 |
| Supplement | S140 |
| Product Code | MCM |
| Advisory Committee | Ear Nose & Throat |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Cochlear Americas 13059 East Peakview Avenue centennial, CO 80111 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P970051 | Original Filing | |
| S216 | 2022-11-21 | Normal 180 Day Track No User Fee |
| S215 | 2022-11-14 | 30-day Notice |
| S214 | 2022-09-07 | Real-time Process |
| S213 | 2022-07-11 | 30-day Notice |
| S212 | ||
| S211 | ||
| S210 | 2022-02-08 | Normal 180 Day Track No User Fee |
| S209 | 2022-02-01 | 30-day Notice |
| S208 | ||
| S207 | 2021-07-13 | Real-time Process |
| S206 | ||
| S205 | ||
| S204 | 2021-02-24 | 30-day Notice |
| S203 | ||
| S202 | 2020-11-18 | 30-day Notice |
| S201 | 2020-11-12 | 30-day Notice |
| S200 | ||
| S199 | 2020-07-15 | 30-day Notice |
| S198 | 2020-04-16 | Normal 180 Day Track No User Fee |
| S197 | ||
| S196 | 2020-02-21 | 30-day Notice |
| S195 | 2020-01-14 | Special (immediate Track) |
| S194 | 2019-11-13 | 30-day Notice |
| S193 | ||
| S192 | 2019-09-09 | 30-day Notice |
| S191 | ||
| S190 | ||
| S189 | 2019-07-31 | 30-day Notice |
| S188 | ||
| S187 | ||
| S186 | 2019-06-06 | 30-day Notice |
| S185 | ||
| S184 | 2019-01-30 | 30-day Notice |
| S183 | ||
| S182 | 2018-11-01 | Normal 180 Day Track |
| S181 | 2018-08-13 | 30-day Notice |
| S180 | 2018-06-11 | Special (immediate Track) |
| S179 | 2018-04-27 | Special (immediate Track) |
| S178 | 2018-04-13 | 30-day Notice |
| S177 | 2018-02-15 | 30-day Notice |
| S176 | 2018-02-02 | 30-day Notice |
| S175 | 2018-01-02 | 30-day Notice |
| S174 | 2018-01-02 | 30-day Notice |
| S173 | 2017-11-13 | Normal 180 Day Track |
| S172 | ||
| S171 | 2017-09-28 | 30-day Notice |
| S170 | 2017-08-25 | 135 Review Track For 30-day Notice |
| S169 | 2017-08-07 | 30-day Notice |
| S168 | 2017-07-26 | 30-day Notice |
| S167 | 2017-07-17 | 30-day Notice |
| S166 | 2017-06-21 | Real-time Process |
| S165 | 2017-06-07 | 30-day Notice |
| S164 | 2017-05-23 | Normal 180 Day Track |
| S163 | 2017-05-16 | 30-day Notice |
| S162 | 2017-04-24 | 30-day Notice |
| S161 | 2017-04-18 | Real-time Process |
| S160 | 2017-04-10 | 30-day Notice |
| S159 | 2017-03-23 | 30-day Notice |
| S158 | 2017-02-27 | 30-day Notice |
| S157 | 2017-02-09 | Special (immediate Track) |
| S156 | 2017-02-07 | 30-day Notice |
| S155 | 2016-12-21 | 30-day Notice |
| S154 | 2016-11-23 | 30-day Notice |
| S153 | 2016-11-23 | 30-day Notice |
| S152 | ||
| S151 | 2016-10-12 | Normal 180 Day Track |
| S150 | 2016-09-22 | 30-day Notice |
| S149 | 2016-07-25 | 30-day Notice |
| S148 | 2016-06-23 | 30-day Notice |
| S147 | 2016-06-15 | 135 Review Track For 30-day Notice |
| S146 | 2016-05-27 | 30-day Notice |
| S145 | 2016-02-24 | 30-day Notice |
| S144 | 2016-02-24 | Normal 180 Day Track |
| S143 | 2016-02-08 | Normal 180 Day Track |
| S142 | 2016-01-06 | 30-day Notice |
| S141 | 2016-01-05 | 30-day Notice |
| S140 | 2015-12-23 | Normal 180 Day Track |
| S139 | 2015-12-17 | 30-day Notice |
| S138 | 2015-12-04 | 30-day Notice |
| S137 | 2015-11-23 | Normal 180 Day Track |
| S136 | 2015-10-23 | 30-day Notice |
| S135 | 2015-10-13 | 30-day Notice |
| S134 | 2015-09-14 | 30-day Notice |
| S133 | 2015-07-31 | Normal 180 Day Track |
| S132 | 2015-07-23 | Normal 180 Day Track No User Fee |
| S131 | 2015-05-18 | 135 Review Track For 30-day Notice |
| S130 | 2015-05-07 | 135 Review Track For 30-day Notice |
| S129 | 2015-03-23 | Real-time Process |
| S128 | 2015-02-13 | 30-day Notice |
| S127 | 2014-12-24 | 30-day Notice |
| S126 | 2014-11-14 | Normal 180 Day Track |
| S125 | 2014-11-12 | 30-day Notice |
| S124 | 2014-11-12 | 30-day Notice |
| S123 | 2014-10-02 | Normal 180 Day Track |
| S122 | 2014-07-23 | 30-day Notice |
| S121 | 2014-06-09 | Real-time Process |
| S120 | 2014-05-16 | 30-day Notice |
| S119 | 2014-04-17 | 30-day Notice |
| S118 | 2014-03-28 | 30-day Notice |
| S117 | ||
| S116 | 2014-01-27 | Normal 180 Day Track |
| S115 | 2014-01-22 | 30-day Notice |
| S114 | 2014-01-15 | Real-time Process |
| S113 | 2013-10-22 | 135 Review Track For 30-day Notice |
| S112 | 2013-09-26 | Real-time Process |
| S111 | 2013-07-29 | 30-day Notice |
| S110 | 2013-06-28 | Normal 180 Day Track |
| S109 | 2013-04-10 | 30-day Notice |
| S108 | 2013-04-04 | 135 Review Track For 30-day Notice |
| S107 | 2013-03-27 | 135 Review Track For 30-day Notice |
| S106 | 2013-02-25 | 30-day Notice |
| S105 | 2013-02-07 | 135 Review Track For 30-day Notice |
| S104 | 2013-01-16 | Normal 180 Day Track |
| S103 | 2012-12-24 | Real-time Process |
| S102 | ||
| S101 | 2012-11-15 | 135 Review Track For 30-day Notice |
| S100 | 2012-11-15 | 135 Review Track For 30-day Notice |
| S099 | ||
| S098 | 2012-10-23 | 30-day Notice |
| S097 | 2012-09-11 | Real-time Process |
| S096 | 2012-08-27 | Normal 180 Day Track |
| S095 | 2012-08-06 | 30-day Notice |
| S094 | 2012-08-02 | Normal 180 Day Track |
| S093 | 2012-07-31 | Real-time Process |
| S092 | 2012-07-27 | 30-day Notice |
| S091 | 2012-07-13 | Normal 180 Day Track |
| S090 | ||
| S089 | 2011-12-30 | Real-time Process |
| S088 | 2011-10-26 | Real-time Process |
| S087 | 2011-09-22 | Real-time Process |
| S086 | 2011-08-29 | 135 Review Track For 30-day Notice |
| S085 | 2011-08-05 | Real-time Process |
| S084 | ||
| S083 | ||
| S082 | 2011-06-29 | 135 Review Track For 30-day Notice |
| S081 | ||
| S080 | 2011-06-27 | 30-day Notice |
| S079 | ||
| S078 | 2011-06-24 | 30-day Notice |
| S077 | 2011-05-19 | 30-day Notice |
| S076 | 2011-05-19 | 30-day Notice |
| S075 | 2011-05-19 | 135 Review Track For 30-day Notice |
| S074 | 2011-05-19 | 135 Review Track For 30-day Notice |
| S073 | 2011-05-19 | 135 Review Track For 30-day Notice |
| S072 | ||
| S071 | 2011-05-16 | 30-day Notice |
| S070 | 2011-05-16 | 135 Review Track For 30-day Notice |
| S069 | 2011-04-06 | Real-time Process |
| S068 | 2011-03-10 | Special (immediate Track) |
| S067 | 2011-02-03 | 30-day Notice |
| S066 | ||
| S065 | 2010-11-19 | 30-day Notice |
| S064 | 2010-10-01 | Normal 180 Day Track |
| S063 | 2010-09-27 | Real-time Process |
| S062 | 2009-12-23 | Real-time Process |
| S061 | ||
| S060 | 2009-12-09 | 135 Review Track For 30-day Notice |
| S059 | 2009-11-09 | 135 Review Track For 30-day Notice |
| S058 | 2009-11-02 | 30-day Notice |
| S057 | 2009-10-26 | 135 Review Track For 30-day Notice |
| S056 | ||
| S055 | 2009-10-13 | Special (immediate Track) |
| S054 | 2009-10-05 | 135 Review Track For 30-day Notice |
| S053 | 2009-09-25 | Normal 180 Day Track |
| S052 | 2009-07-22 | 135 Review Track For 30-day Notice |
| S051 | 2009-06-11 | 30-day Notice |
| S050 | 2009-05-20 | Real-time Process |
| S049 | 2008-12-19 | Normal 180 Day Track |
| S048 | 2008-11-25 | Normal 180 Day Track |
| S047 | 2008-08-08 | 30-day Notice |
| S046 | 2008-07-25 | 30-day Notice |
| S045 | 2007-10-09 | Real-time Process |
| S044 | 2007-08-24 | 30-day Notice |
| S043 | 2007-08-24 | 30-day Notice |
| S042 | 2007-08-24 | 30-day Notice |
| S041 | 2007-08-24 | 30-day Notice |
| S040 | ||
| S039 | 2006-09-05 | 30-day Notice |
| S038 | 2006-04-21 | Real-time Process |
| S037 | 2006-04-13 | Real-time Process |
| S036 | 2006-01-24 | 30-day Notice |
| S035 | 2005-12-20 | Real-time Process |
| S034 | 2005-09-23 | Real-time Process |
| S033 | ||
| S032 | ||
| S031 | 2005-03-15 | Real-time Process |
| S030 | 2005-03-09 | 30-day Notice |
| S029 | 2004-09-17 | Normal 180 Day Track |
| S028 | 2004-07-01 | Normal 180 Day Track |
| S027 | 2003-10-06 | Real-time Process |
| S026 | 2003-09-04 | Real-time Process |
| S025 | 2003-08-13 | Normal 180 Day Track No User Fee |
| S024 | 2002-12-06 | Normal 180 Day Track |
| S023 | 2002-10-31 | Normal 180 Day Track |
| S022 | 2002-08-28 | Special (immediate Track) |
| S021 | 2002-07-16 | Normal 180 Day Track |
| S020 | 2002-06-13 | Real-time Process |
| S019 | 2001-10-23 | Normal 180 Day Track |
| S018 | 2001-07-23 | Normal 180 Day Track |
| S017 | 2001-06-22 | Normal 180 Day Track |
| S016 | 2001-04-19 | Normal 180 Day Track |
| S015 | 2001-03-19 | Normal 180 Day Track |
| S014 | 2001-01-16 | Real-time Process |
| S013 | 2000-12-29 | Normal 180 Day Track |
| S012 | 2000-11-29 | Normal 180 Day Track |
| S011 | 2000-07-21 | Normal 180 Day Track |
| S010 | 2000-02-23 | Normal 180 Day Track |
| S009 | 1999-12-17 | Real-time Process |
| S008 | 1999-09-20 | Normal 180 Day Track |
| S007 | 1999-08-13 | Real-time Process |
| S006 | 1999-04-15 | 30-day Notice |
| S005 | 1999-03-26 | Real-time Process |
| S004 | 1999-01-08 | Normal 180 Day Track |
| S003 | 1998-08-17 | Normal 180 Day Track |
| S002 | 1998-07-20 | Real-time Process |
| S001 | 1998-07-16 | Normal 180 Day Track |