TY - JOUR
T1 - Early Osia® 2 bone conduction hearing implant experience
T2 - Nationwide controlled-market release data and single-center outcomes
AU - Goldstein, Mary Rose
AU - Bourn, Stephanie
AU - Jacob, Abraham
N1 - Funding Information:
We thank the Osia® recipients that participated in the Controlled Market Release (CMR) and in the study, together with all the colleagues at the participating CMR centers (Arizona Hearing Center, Phoenix, AZ; Arizona Ear Institute, Phoenix, AZ; Baylor College of Medicine, Houston, TX; Center for Hearing and Balance Disorders, Chesterfield, MO; Center for Neurosciences, Tucson, AZ; Children's Mercy Hospital, Kansas City, MO; Cochlear Hearing Center, San Antonio, TX; Ear Medical Group, San Antonio, TX; ENT Surgeons of Western New England, Springfield, MA; Ear, Nose, and Throat Associates at the Greater Baltimore Medical Center, Baltimore, MD; House Ear Institute, Los Angeles, CA; Idaho Ear Clinic, Boise, ID; Johns Hopkins Health System, Baltimore, MD; Loyola University Medical Center, Maywood, IL; Macias Otology, Phoenix, AZ; Massachusetts Eye and Ear Infirmary, Boston, MA; Michigan Ear Institute, Farmington Hills, MI; NYU Langone Health, New York, NY; Ohio State Eye and Ear Institute, Columbus, OH; Otologic Center, Inc. Kansas City, MO; Hospital of the University of Pennsylvania, Philadelphia, PA; Prevea Health, Green Bay, WI; Rush University Medical Center, Chicago, IL; Silverstein Institute, Sarasota, FL; Texas Children's Hospital, Houston, TX; The New York Eye and Ear Infirmary of Mount Sinai, New York, NY; University of Colorado, Aurora, CO; University of Iowa, Iowa City, IA; University of Massachusetts Medical Center, Worcester, MA; University of Miami Ear Institute, Miami, FL; University of Michigan, Cochlear Implant Program, Ann Arbor, MI; UT Southwestern Medical Center, Dallas, TX; Vanderbilt, Nashville, TN; Washington University, St. Louis, MO; West Virginia University Hospital, Morgantown, WV).
Publisher Copyright:
© 2020
PY - 2021/1/1
Y1 - 2021/1/1
N2 - Purpose: Bone conduction hearing devices are a well-established treatment option for conductive or mixed hearing losses as well as single-sided deafness. The Osia® 2 System is an active osseointegrated device where a surgically implanted titanium fixture supports a newly developed piezoelectric actuator that is placed under the skin. Methods: Nationwide data collected during a controlled-market release (CMR) of the Cochlear™ Osia® 2 System as well as outcomes at single, tertiary-level private practice Otology/Neurotology center were retrospectively reviewed. Key learnings from surgeons and audiologists are discussed. Results: During the CMR period, 23 surgeons performed 44 operations on 43 recipients. The mean age of recipients was 44 years and mean surgery duration was 52 min. The most commonly used incision was postauricular but anterior to the device (78%). Five complications were observed during the CMR, none of which were device related. Twenty-one audiologists performed 33 Osia® 2 activations during the CMR. The mean age of this group was 47 years, and the mean duration of each activation appointment was 55 min. Single-center data at the authors' institution demonstrated an average additional PTA4 gain with the Osia® 2 patients of 9.6 dB compared to Baha Attract and 10.2 dB compared to Baha Connect. Conclusion: The Cochlear™ Osia® 2 System represents a significant advance in auditory osseointegrated implant technology. Digital piezoelectric stimulation delivers high power outputs, improves high frequency gain for optimal speech perception, and maintains safety while providing excellent patient satisfaction.
AB - Purpose: Bone conduction hearing devices are a well-established treatment option for conductive or mixed hearing losses as well as single-sided deafness. The Osia® 2 System is an active osseointegrated device where a surgically implanted titanium fixture supports a newly developed piezoelectric actuator that is placed under the skin. Methods: Nationwide data collected during a controlled-market release (CMR) of the Cochlear™ Osia® 2 System as well as outcomes at single, tertiary-level private practice Otology/Neurotology center were retrospectively reviewed. Key learnings from surgeons and audiologists are discussed. Results: During the CMR period, 23 surgeons performed 44 operations on 43 recipients. The mean age of recipients was 44 years and mean surgery duration was 52 min. The most commonly used incision was postauricular but anterior to the device (78%). Five complications were observed during the CMR, none of which were device related. Twenty-one audiologists performed 33 Osia® 2 activations during the CMR. The mean age of this group was 47 years, and the mean duration of each activation appointment was 55 min. Single-center data at the authors' institution demonstrated an average additional PTA4 gain with the Osia® 2 patients of 9.6 dB compared to Baha Attract and 10.2 dB compared to Baha Connect. Conclusion: The Cochlear™ Osia® 2 System represents a significant advance in auditory osseointegrated implant technology. Digital piezoelectric stimulation delivers high power outputs, improves high frequency gain for optimal speech perception, and maintains safety while providing excellent patient satisfaction.
KW - Audiology
KW - Aural rehabilitation
KW - Baha
KW - Bone conduction hearing implant
KW - Bone-anchored hearing devices
KW - Osia
KW - Otology
UR - http://www.scopus.com/inward/record.url?scp=85095439101&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85095439101&partnerID=8YFLogxK
U2 - 10.1016/j.amjoto.2020.102818
DO - 10.1016/j.amjoto.2020.102818
M3 - Article
C2 - 33166860
AN - SCOPUS:85095439101
SN - 0196-0709
VL - 42
JO - American Journal of Otolaryngology - Head and Neck Medicine and Surgery
JF - American Journal of Otolaryngology - Head and Neck Medicine and Surgery
IS - 1
M1 - 102818
ER -