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 expanding the indications to include the electro-acoustic stimulation (eas) system that is intended to provide electrical stimulation to the mid- to high-frequency region of the cochlea and acoustic amplification to the low-frequency regions, for candidates with residual low frequency hearing sensitivity. The med-el eas system is indicated for partially deaf individuals aged 18 years and older who have residual hearing sensitivity in the low frequencies sloping to a severe/profound sensorineural hearing loss in the mid to high frequencies, and who obtain minimal benefit from conventional acoustic amplification. Typical preoperative hearing of candidates ranges from normal hearing to moderate sensorineural hearing loss in the low frequencies (thresholds no poorer than 65 db hl up to and including 500 hz) with severe to profound mid- to high-frequency hearing loss (no better than 70 db hl at 2000 hz and above) in the ear to be implanted. For the non-implanted ear, thresholds may be worse than the criteria for the implanted ear, but may not be better. The cnc word recognition score in quiet in the best-aided condition will be 60% or less, in the ear to be implanted and in the contralateral ear. Prospective candidates should go through a suitable hearing aid trial, unless already appropriately fit with hearing aids.
| Device | MED-EL COCHLEAR IMPLANT SYSTEM |
| Classification Name | Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification |
| Generic Name | Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification |
| Applicant | MED-EL CORP. |
| Date Received | 2015-12-23 |
| Decision Date | 2016-09-15 |
| Notice Date | 2016-09-26 |
| PMA | P000025 |
| Supplement | S084 |
| Product Code | PGQ |
| Docket Number | 16M-2974 |
| Advisory Committee | Ear Nose & Throat |
| Supplement Type | Panel Track |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | MED-EL CORP. furstenweg 77a innsbruck 6020 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Post-Approval Study: | Show Report Schedule and Study Progress |
| Approval Order: | Approval Order |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P000025 | Original Filing | |
| S124 | 2022-02-17 | Real-time Process |
| S123 | 2022-01-26 | Real-time Process |
| S122 | 2021-05-14 | Normal 180 Day Track No User Fee |
| S121 | ||
| S120 | 2020-09-28 | Normal 180 Day Track |
| S119 | 2020-09-21 | 30-day Notice |
| S118 | 2020-08-06 | Normal 180 Day Track No User Fee |
| S117 | ||
| S116 | 2020-05-27 | Real-time Process |
| S115 | ||
| S114 | ||
| S113 | 2019-08-16 | Normal 180 Day Track No User Fee |
| S112 | 2019-05-24 | Real-time Process |
| S111 | ||
| S110 | 2019-03-06 | Real-time Process |
| S109 | 2019-01-31 | Real-time Process |
| S108 | 2019-01-31 | Real-time Process |
| S107 | 2019-01-25 | 30-day Notice |
| S106 | ||
| S105 | 2018-08-20 | 30-day Notice |
| S104 | ||
| S103 | 2018-07-18 | Normal 180 Day Track |
| S102 | 2018-07-12 | 30-day Notice |
| S101 | 2018-06-25 | 30-day Notice |
| S100 | ||
| S099 | 2018-02-14 | Real-time Process |
| S098 | 2018-01-22 | Real-time Process |
| S097 | 2017-12-11 | Normal 180 Day Track |
| S096 | 2017-06-12 | 30-day Notice |
| S095 | 2017-05-05 | 30-day Notice |
| S094 | 2017-03-16 | Normal 180 Day Track |
| S093 | 2017-02-27 | 30-day Notice |
| S092 | 2016-10-13 | Normal 180 Day Track No User Fee |
| S091 | 2016-09-22 | Real-time Process |
| S090 | 2016-08-29 | Real-time Process |
| S089 | 2016-08-22 | Normal 180 Day Track |
| S088 | 2016-06-09 | 30-day Notice |
| S087 | 2016-02-29 | Real-time Process |
| S086 | 2016-02-11 | Real-time Process |
| S085 | 2016-02-01 | Real-time Process |
| S084 | 2015-12-23 | Panel Track |
| S083 | 2015-11-30 | 30-day Notice |
| S082 | 2015-09-04 | Real-time Process |
| S081 | 2014-12-11 | Real-time Process |
| S080 | 2014-08-06 | 30-day Notice |
| S079 | 2014-06-09 | Normal 180 Day Track |
| S078 | 2014-06-09 | Normal 180 Day Track |
| S077 | 2014-04-03 | Real-time Process |
| S076 | 2014-02-20 | 30-day Notice |
| S075 | ||
| S074 | 2013-12-18 | 30-day Notice |
| S073 | 2013-07-19 | 30-day Notice |
| S072 | 2013-07-10 | 135 Review Track For 30-day Notice |
| S071 | 2013-07-10 | 30-day Notice |
| S070 | 2013-06-27 | Real-time Process |
| S069 | 2013-05-06 | 30-day Notice |
| S068 | 2013-03-01 | Real-time Process |
| S067 | 2012-10-26 | Normal 180 Day Track |
| S066 | 2012-11-05 | 30-day Notice |
| S065 | 2012-09-17 | 30-day Notice |
| S064 | 2012-09-04 | Real-time Process |
| S063 | 2012-08-10 | Normal 180 Day Track |
| S062 | 2012-04-05 | Normal 180 Day Track |
| S061 | 2012-02-08 | 30-day Notice |
| S060 | 2011-12-16 | Real-time Process |
| S059 | 2011-10-17 | Real-time Process |
| S058 | 2011-10-17 | Normal 180 Day Track |
| S057 | 2011-10-14 | Normal 180 Day Track |
| S056 | 2011-08-29 | 30-day Notice |
| S055 | 2011-08-04 | 30-day Notice |
| S054 | 2011-06-20 | Real-time Process |
| S053 | 2011-05-31 | 135 Review Track For 30-day Notice |
| S052 | 2011-05-23 | Real-time Process |
| S051 | 2011-04-25 | 135 Review Track For 30-day Notice |
| S050 | 2010-12-27 | Normal 180 Day Track |
| S049 | 2010-07-06 | 30-day Notice |
| S048 | 2010-05-19 | 30-day Notice |
| S047 | 2010-04-28 | 135 Review Track For 30-day Notice |
| S046 | 2010-03-18 | 135 Review Track For 30-day Notice |
| S045 | 2009-12-17 | Normal 180 Day Track |
| S044 | 2009-11-02 | 135 Review Track For 30-day Notice |
| S043 | 2009-07-31 | Real-time Process |
| S042 | 2009-05-04 | Real-time Process |
| S041 | 2009-04-22 | 135 Review Track For 30-day Notice |
| S040 | 2009-02-23 | 30-day Notice |
| S039 | 2009-02-18 | Real-time Process |
| S038 | 2008-09-24 | 30-day Notice |
| S037 | 2008-09-12 | Special (immediate Track) |
| S036 | 2008-06-27 | Normal 180 Day Track No User Fee |
| S035 | 2008-06-25 | Normal 180 Day Track |
| S034 | 2008-05-12 | 30-day Notice |
| S033 | 2008-04-28 | Real-time Process |
| S032 | 2008-03-10 | 30-day Notice |
| S031 | 2008-01-23 | 30-day Notice |
| S030 | ||
| S029 | 2007-10-25 | Normal 180 Day Track |
| S028 | 2007-09-27 | 30-day Notice |
| S027 | 2007-08-27 | Special (immediate Track) |
| S026 | 2007-07-18 | Normal 180 Day Track |
| S025 | 2007-06-29 | 30-day Notice |
| S024 | 2007-06-27 | 30-day Notice |
| S023 | 2007-03-29 | Normal 180 Day Track |
| S022 | ||
| S021 | 2006-12-15 | Normal 180 Day Track |
| S020 | 2006-04-17 | Real-time Process |
| S019 | 2005-07-05 | Real-time Process |
| S018 | 2005-02-04 | 30-day Notice |
| S017 | 2004-12-17 | Normal 180 Day Track |
| S016 | ||
| S015 | ||
| S014 | 2004-03-08 | Normal 180 Day Track |
| S013 | 2004-01-26 | 30-day Notice |
| S012 | 2003-12-16 | Normal 180 Day Track |
| S011 | 2003-06-18 | Normal 180 Day Track No User Fee |
| S010 | 2003-06-16 | Real-time Process |
| S009 | 2003-03-31 | Normal 180 Day Track |
| S008 | 2003-01-21 | Special (immediate Track) |
| S007 | 2002-12-10 | Normal 180 Day Track |
| S006 | 2002-11-01 | Normal 180 Day Track |
| S005 | 2002-10-15 | Real-time Process |
| S004 | 2002-08-20 | Real-time Process |
| S003 | 2002-03-25 | 30-day Notice |
| S002 | 2002-02-21 | Normal 180 Day Track |
| S001 | 2001-12-18 | Normal 180 Day Track |