Nucleus Freedom North American clinical trial

Thomas Balkany; Annelle Hodges; Christine Menapace; Linda Hazard; Colin Driscoll; Bruce Gantz; David Kelsall; William Luxford; Sean McMenomy; J. Gail Neely; Brian Peters; Harold Pillsbury; Joseph Roberson; David Schramm; Steven Telian; Susan Waltzman; Brian Westerberg; Stacy Payne

doi:10.1016/j.otohns.2007.01.006

Nucleus Freedom North American clinical trial

Thomas Balkany, Annelle Hodges, Christine Menapace, Linda Hazard, Colin Driscoll, Bruce Gantz, David Kelsall, William Luxford, Sean McMenomy, J. Gail Neely, Brian Peters, Harold Pillsbury, Joseph Roberson, David Schramm, Steven Telian, Susan Waltzman, Brian Westerberg, Stacy Payne

Otolaryngology

Research output: Contribution to journal › Article

67 Scopus citations

Abstract

Objective: To evaluate hearing outcomes and effects of stimulation rate on performance with the Nucleus Freedom cochlear implant (Cochlear Americas, Denver, CO). Study Design and Setting: Randomized, controlled, prospective, single-blind clinical study using single-subject repeated measures (A-B-A-B) design at 14 academic centers in the United States and Canada and comparison with outcomes of a prior device by the same manufacturer. Patients: Seventy-one severely/profoundly hearing impaired adults. Results: Seventy-one adult recipients were randomly programmed in two different sets of rate: ACE or higher rate ACE RE. Mean scores for Consonant Nucleus Consonant words is 57%, Hearing in Noise Test (HINT) sentences in quiet 78%, and HINT sentences in noise 64%. Sixty-seven percent of subjects preferred slower rates of stimulation, and performance did not improve with higher rates of stimulation using this device. Conclusions: Subjects performed well, and there was no advantage to higher stimulation rates with this device. Significance: Higher stimulation rates do not necessarily result in improved performance.

Original language	English (US)
Pages (from-to)	757-762
Number of pages	6
Journal	Otolaryngology - Head and Neck Surgery
Volume	136
Issue number	5
DOIs	https://doi.org/10.1016/j.otohns.2007.01.006
State	Published - May 2007

ASJC Scopus subject areas

Surgery
Otorhinolaryngology

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Balkany, T., Hodges, A., Menapace, C., Hazard, L., Driscoll, C., Gantz, B., Kelsall, D., Luxford, W., McMenomy, S., Neely, J. G., Peters, B., Pillsbury, H., Roberson, J., Schramm, D., Telian, S., Waltzman, S., Westerberg, B., & Payne, S. (2007). Nucleus Freedom North American clinical trial. Otolaryngology - Head and Neck Surgery, 136(5), 757-762. https://doi.org/10.1016/j.otohns.2007.01.006

Nucleus Freedom North American clinical trial. / Balkany, Thomas; Hodges, Annelle; Menapace, Christine; Hazard, Linda; Driscoll, Colin; Gantz, Bruce; Kelsall, David; Luxford, William; McMenomy, Sean; Neely, J. Gail; Peters, Brian; Pillsbury, Harold; Roberson, Joseph; Schramm, David; Telian, Steven; Waltzman, Susan; Westerberg, Brian; Payne, Stacy.

In: Otolaryngology - Head and Neck Surgery, Vol. 136, No. 5, 05.2007, p. 757-762.

Research output: Contribution to journal › Article

Balkany, T, Hodges, A, Menapace, C, Hazard, L, Driscoll, C, Gantz, B, Kelsall, D, Luxford, W, McMenomy, S, Neely, JG, Peters, B, Pillsbury, H, Roberson, J, Schramm, D, Telian, S, Waltzman, S, Westerberg, B & Payne, S 2007, 'Nucleus Freedom North American clinical trial', Otolaryngology - Head and Neck Surgery, vol. 136, no. 5, pp. 757-762. https://doi.org/10.1016/j.otohns.2007.01.006

Balkany, Thomas ; Hodges, Annelle ; Menapace, Christine ; Hazard, Linda ; Driscoll, Colin ; Gantz, Bruce ; Kelsall, David ; Luxford, William ; McMenomy, Sean ; Neely, J. Gail ; Peters, Brian ; Pillsbury, Harold ; Roberson, Joseph ; Schramm, David ; Telian, Steven ; Waltzman, Susan ; Westerberg, Brian ; Payne, Stacy. / Nucleus Freedom North American clinical trial. In: Otolaryngology - Head and Neck Surgery. 2007 ; Vol. 136, No. 5. pp. 757-762.

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AU - Menapace, Christine

AU - Hazard, Linda

AU - Driscoll, Colin

AU - Gantz, Bruce

AU - Kelsall, David

AU - Luxford, William

AU - McMenomy, Sean

AU - Neely, J. Gail

AU - Peters, Brian

AU - Pillsbury, Harold

AU - Roberson, Joseph

AU - Schramm, David

AU - Telian, Steven

AU - Waltzman, Susan

AU - Westerberg, Brian

AU - Payne, Stacy

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AB - Objective: To evaluate hearing outcomes and effects of stimulation rate on performance with the Nucleus Freedom cochlear implant (Cochlear Americas, Denver, CO). Study Design and Setting: Randomized, controlled, prospective, single-blind clinical study using single-subject repeated measures (A-B-A-B) design at 14 academic centers in the United States and Canada and comparison with outcomes of a prior device by the same manufacturer. Patients: Seventy-one severely/profoundly hearing impaired adults. Results: Seventy-one adult recipients were randomly programmed in two different sets of rate: ACE or higher rate ACE RE. Mean scores for Consonant Nucleus Consonant words is 57%, Hearing in Noise Test (HINT) sentences in quiet 78%, and HINT sentences in noise 64%. Sixty-seven percent of subjects preferred slower rates of stimulation, and performance did not improve with higher rates of stimulation using this device. Conclusions: Subjects performed well, and there was no advantage to higher stimulation rates with this device. Significance: Higher stimulation rates do not necessarily result in improved performance.

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