Objectives: The objective of this study was to test the ability to achieve, maintain, and subjectively benefit from extended high-frequency amplification in a real-world use scenario, with a device that restores audibility for frequencies up to 10 kHz. Design: A total of 78 participants (149 ears) with mild to moderately-severe sensorineural hearing loss completed one of two studies conducted across eight clinical sites. Participants were fitted with a light-driven contact hearing aid (the Earlens system) that directly drives the tympanic membrane, allowing extended high-frequency output and amplification with minimal acoustic feedback. Cambridge Method for Loudness Equalization 2 - High Frequency (CAM2)-prescribed gains for experienced users were used for initial fitting, and adjustments were made when required according to participant preferences for loudness and comfort or when measures of functional gain (FG) indicated that more or less gain was needed. Participants wore the devices for an extended period. Prescribed versus adjusted output and gain, frequency-specific FG, and self-perceived benefit assessed with the Abbreviated Profile of Hearing Aid Benefit, and a custom questionnaire were documented. Self-perceived benefit results were compared with those for unaided listening and to ratings with participants’ own acoustic hearing aids. Results: The prescribed low-level insertion gain from 6 to 10 kHz averaged 53 dB across all ears, with a range from 26 to 86 dB. After adjustment, the gain from 6 to 10 kHz decreased to an average of 45 dB with a range from 16 to 86 dB. Measured FG averaged 39 dB from 6 to 10 kHz with a range from 11 to 62 dB. Abbreviated Profile of Hearing Aid Benefit results revealed a significant improvement in communication relative to unaided listening, averaging 28 to 32 percentage points for the background noise, reverberation, and ease of communication subscales. Relative to participants’ own hearing aids, the subscales ease of communication and aversiveness showed small but significant improvements for Earlens ranging from 6 to 7 percentage points. For the custom satisfaction questionnaire, most participants rated the Earlens system as better than their own hearing aids in most situations. Conclusions: Participants used and reported subjective benefit from the Earlens system. Most participants preferred slightly less gain at 6 to 10 kHz than prescribed for experienced users by CAM2, preferring similar gains to those prescribed for inexperienced users, but gains over the extended high frequencies were high relative to those that are currently available with acoustic hearing aids. This is an open access article distributed under the Creative Commons Attribution License 4.0 (CCBY), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Supplemental digital content is available for this article. Direct URL citations appear in the printed text and are provided in the HTML and text of this article on the journal’s Web site (www.ear-hearing.com). ACKNOWLEDGMENTS: The authors express their appreciation to the study participants, to the Clinical Investigators who treated and counseled the participants and collected the study data, and to Tim Streeter for assistance with fitting software data extraction and analysis. The research was partially supported by SBIR Phase IIB grant R44 DC 08499 from the National Institute on Deafness and Other Communication Disorders (NIDCD) of the National Institutes of Health. Portions of the data in this article were presented at the International Hearing Aid Research Conference (IHCON), Tahoe City, CA, August 10–14, 2016. Results from three Earlens Patient Satisfaction questions from study 1 were presented in a different format in Gantz et al. (2017). For study 2, functional gain, APHAB, and patient satisfaction results were presented for a different purpose or different format in McElveen et al. (Reference Note 1). This work was funded in part by SBIR Phase IIB grant R44 DC 08499 from the NIDCD of NIH. Remaining funding provided by Earlens Corporation. The authors are/were employed by or are consultants for Earlens Corporation, manufacturer of the Light-Driven Contact Hearing Aid. Presenting data for clinical trials registered at ClinicalTrials.gov: NCT02042404/NCT02470494. Address for correspondence: Tanya L. Arbogast, Clinical Research, Earlens Corporation, 4045A Campbell Avenue, Menlo Park, CA 94025, USA. E-mail: Tanya.Arbogast@earlens.com Received November 1, 2017; accepted August 7, 2018. Copyright © 2018 Wolters Kluwer Health, Inc. All rights reserved.
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Τρίτη 9 Οκτωβρίου 2018
Achieved Gain and Subjective Outcomes for a Wide-Bandwidth Contact Hearing Aid Fitted Using CAM2
Objectives: The objective of this study was to test the ability to achieve, maintain, and subjectively benefit from extended high-frequency amplification in a real-world use scenario, with a device that restores audibility for frequencies up to 10 kHz. Design: A total of 78 participants (149 ears) with mild to moderately-severe sensorineural hearing loss completed one of two studies conducted across eight clinical sites. Participants were fitted with a light-driven contact hearing aid (the Earlens system) that directly drives the tympanic membrane, allowing extended high-frequency output and amplification with minimal acoustic feedback. Cambridge Method for Loudness Equalization 2 - High Frequency (CAM2)-prescribed gains for experienced users were used for initial fitting, and adjustments were made when required according to participant preferences for loudness and comfort or when measures of functional gain (FG) indicated that more or less gain was needed. Participants wore the devices for an extended period. Prescribed versus adjusted output and gain, frequency-specific FG, and self-perceived benefit assessed with the Abbreviated Profile of Hearing Aid Benefit, and a custom questionnaire were documented. Self-perceived benefit results were compared with those for unaided listening and to ratings with participants’ own acoustic hearing aids. Results: The prescribed low-level insertion gain from 6 to 10 kHz averaged 53 dB across all ears, with a range from 26 to 86 dB. After adjustment, the gain from 6 to 10 kHz decreased to an average of 45 dB with a range from 16 to 86 dB. Measured FG averaged 39 dB from 6 to 10 kHz with a range from 11 to 62 dB. Abbreviated Profile of Hearing Aid Benefit results revealed a significant improvement in communication relative to unaided listening, averaging 28 to 32 percentage points for the background noise, reverberation, and ease of communication subscales. Relative to participants’ own hearing aids, the subscales ease of communication and aversiveness showed small but significant improvements for Earlens ranging from 6 to 7 percentage points. For the custom satisfaction questionnaire, most participants rated the Earlens system as better than their own hearing aids in most situations. Conclusions: Participants used and reported subjective benefit from the Earlens system. Most participants preferred slightly less gain at 6 to 10 kHz than prescribed for experienced users by CAM2, preferring similar gains to those prescribed for inexperienced users, but gains over the extended high frequencies were high relative to those that are currently available with acoustic hearing aids. This is an open access article distributed under the Creative Commons Attribution License 4.0 (CCBY), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Supplemental digital content is available for this article. Direct URL citations appear in the printed text and are provided in the HTML and text of this article on the journal’s Web site (www.ear-hearing.com). ACKNOWLEDGMENTS: The authors express their appreciation to the study participants, to the Clinical Investigators who treated and counseled the participants and collected the study data, and to Tim Streeter for assistance with fitting software data extraction and analysis. The research was partially supported by SBIR Phase IIB grant R44 DC 08499 from the National Institute on Deafness and Other Communication Disorders (NIDCD) of the National Institutes of Health. Portions of the data in this article were presented at the International Hearing Aid Research Conference (IHCON), Tahoe City, CA, August 10–14, 2016. Results from three Earlens Patient Satisfaction questions from study 1 were presented in a different format in Gantz et al. (2017). For study 2, functional gain, APHAB, and patient satisfaction results were presented for a different purpose or different format in McElveen et al. (Reference Note 1). This work was funded in part by SBIR Phase IIB grant R44 DC 08499 from the NIDCD of NIH. Remaining funding provided by Earlens Corporation. The authors are/were employed by or are consultants for Earlens Corporation, manufacturer of the Light-Driven Contact Hearing Aid. Presenting data for clinical trials registered at ClinicalTrials.gov: NCT02042404/NCT02470494. Address for correspondence: Tanya L. Arbogast, Clinical Research, Earlens Corporation, 4045A Campbell Avenue, Menlo Park, CA 94025, USA. E-mail: Tanya.Arbogast@earlens.com Received November 1, 2017; accepted August 7, 2018. Copyright © 2018 Wolters Kluwer Health, Inc. All rights reserved.
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Impact of Gait Analysis on Pathology Identification and Surgical Recommendations in Children with Spina Bifida
Publication date: Available online 9 October 2018
Source: Gait & Posture
Author(s): Nicole M. Mueske, Sylvia Õunpuu, Deirdre D. Ryan, Bitte S. Healy, Jeffrey Thomson, Paul Choi, Tishya A.L. Wren
Abstract
BACKGROUND
Gait analysis provides quantitative data that can be used to supplement standard clinical evaluation in identifying and understanding gait problems. It has been established that gait analysis changes treatment decision making for children with cerebral palsy, but this has not yet been studied in other diagnoses such as spina bifida.
RESEARCH QUESTION
To determine the effects of gait analysis data on pathology identification and surgical recommendations in children with spina bifida.
METHODS
Two pediatric orthopaedic surgeons and two therapists with >10 years of experience in gait analysis reviewed clinical, video, and gait analysis data from 43 ambulatory children with spina bifida (25 male; mean age 11.7 years, SD 3.8; 25 sacral, 18 lumbar). Primary gait pathologies were identified by each assessor both before and after consideration of the gait analysis data. Surgical recommendations were also recorded by the surgeons before and after consideration of the gait analysis data. Frequencies of pathology and surgery identification with and without gait analysis were compared using Fisher’s exact test, and percent change in pathology and surgery identification was calculated.
RESULTS
Pathology identification often changed for common gait problems including crouch (28% of cases), tibial rotation (35%), pes valgus (18%), excessive hip flexion (70%), and abnormal femur rotation (75%). Recognition of excessive hip flexion and abnormal femur rotation increased significantly after consideration of gait analysis data (p < 0.05). Surgical recommendations also frequently changed for the most common surgeries including tibial derotation osteotomy (30%), antero-lateral release (22%), plantar fascia release (33%), knee capsulotomy (25%), 1st metatarsal osteotomy (60%), and femoral derotation osteotomy (89%). At the patient level, consideration of gait analysis data altered surgical recommendations for 44% of patients.
SIGNIFICANCE
Since gait analysis data often changes pathology identification and surgical recommendations, treatment decision making may be improved by including gait analysis in the patient care process.
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Spatiotemporal variability underlying skill in curved-path walking
Publication date: Available online 9 October 2018
Source: Gait & Posture
Author(s): KayLynn Bland, Kristin Lowry, Alex Krajek, Taylor Woods, Jessie VanSwearingen
Abstract
Background
Daily life walking frequently involves curved paths. While mean gait characteristics and orientation of the body during curved path walking have been described, little has been reported about spatiotemporal variability during curved path walking and its relation to the motor skill of walking in older adults.
Research question
Among community-dwelling older adults, is greater spatiotemporal variability during curved path walking related to better curved path walking ability?
Methods
Community dwelling older adults (n = 34) completed the Figure-of-8 Walk Test (F8W, a measure of curved path walking ability) and usual straight path walking on an instrumented walkway. Standard deviations for step length, stride width and step time (step length variability, SLV, stride width variability, SWV, step time variability, STV) during both conditions were determined, along with time and number of steps to complete F8W. Associations were examined with Pearson r correlation coefficients, regressions determined contributions of variability during curved path walking to F8W performance, and AUC analyses were used to determine the ability of variability during curved path walking to distinguish better vs poorer F8W performance.
Results
F8W time and steps were negatively associated with both SLV (r’s = -.37, p < 0.05) and SWV (r’s = -.67 to -.82, p < .001). Both SLV and SWV independently contributed to F8W performance (SLV βs = -.26 to -.29, p < 0.03; SWV βs = -.74 to -.76, p < 0.001). The AUC of the ROC curve for SLV was 0.716, and for SWV was 0.765.
Significance
Greater spatial variability, particularly SWV, was associated with better motor skill of curved path walking. It is important for clinicians to understand the variables that contribute to successful performance of complex walking tasks as these can be targets for rehabilitation. The findings suggest that practice of adjustment of stride width and step length during walking are important.
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Impact of Gait Analysis on Pathology Identification and Surgical Recommendations in Children with Spina Bifida
Publication date: Available online 9 October 2018
Source: Gait & Posture
Author(s): Nicole M. Mueske, Sylvia Õunpuu, Deirdre D. Ryan, Bitte S. Healy, Jeffrey Thomson, Paul Choi, Tishya A.L. Wren
Abstract
BACKGROUND
Gait analysis provides quantitative data that can be used to supplement standard clinical evaluation in identifying and understanding gait problems. It has been established that gait analysis changes treatment decision making for children with cerebral palsy, but this has not yet been studied in other diagnoses such as spina bifida.
RESEARCH QUESTION
To determine the effects of gait analysis data on pathology identification and surgical recommendations in children with spina bifida.
METHODS
Two pediatric orthopaedic surgeons and two therapists with >10 years of experience in gait analysis reviewed clinical, video, and gait analysis data from 43 ambulatory children with spina bifida (25 male; mean age 11.7 years, SD 3.8; 25 sacral, 18 lumbar). Primary gait pathologies were identified by each assessor both before and after consideration of the gait analysis data. Surgical recommendations were also recorded by the surgeons before and after consideration of the gait analysis data. Frequencies of pathology and surgery identification with and without gait analysis were compared using Fisher’s exact test, and percent change in pathology and surgery identification was calculated.
RESULTS
Pathology identification often changed for common gait problems including crouch (28% of cases), tibial rotation (35%), pes valgus (18%), excessive hip flexion (70%), and abnormal femur rotation (75%). Recognition of excessive hip flexion and abnormal femur rotation increased significantly after consideration of gait analysis data (p < 0.05). Surgical recommendations also frequently changed for the most common surgeries including tibial derotation osteotomy (30%), antero-lateral release (22%), plantar fascia release (33%), knee capsulotomy (25%), 1st metatarsal osteotomy (60%), and femoral derotation osteotomy (89%). At the patient level, consideration of gait analysis data altered surgical recommendations for 44% of patients.
SIGNIFICANCE
Since gait analysis data often changes pathology identification and surgical recommendations, treatment decision making may be improved by including gait analysis in the patient care process.
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Spatiotemporal variability underlying skill in curved-path walking
Publication date: Available online 9 October 2018
Source: Gait & Posture
Author(s): KayLynn Bland, Kristin Lowry, Alex Krajek, Taylor Woods, Jessie VanSwearingen
Abstract
Background
Daily life walking frequently involves curved paths. While mean gait characteristics and orientation of the body during curved path walking have been described, little has been reported about spatiotemporal variability during curved path walking and its relation to the motor skill of walking in older adults.
Research question
Among community-dwelling older adults, is greater spatiotemporal variability during curved path walking related to better curved path walking ability?
Methods
Community dwelling older adults (n = 34) completed the Figure-of-8 Walk Test (F8W, a measure of curved path walking ability) and usual straight path walking on an instrumented walkway. Standard deviations for step length, stride width and step time (step length variability, SLV, stride width variability, SWV, step time variability, STV) during both conditions were determined, along with time and number of steps to complete F8W. Associations were examined with Pearson r correlation coefficients, regressions determined contributions of variability during curved path walking to F8W performance, and AUC analyses were used to determine the ability of variability during curved path walking to distinguish better vs poorer F8W performance.
Results
F8W time and steps were negatively associated with both SLV (r’s = -.37, p < 0.05) and SWV (r’s = -.67 to -.82, p < .001). Both SLV and SWV independently contributed to F8W performance (SLV βs = -.26 to -.29, p < 0.03; SWV βs = -.74 to -.76, p < 0.001). The AUC of the ROC curve for SLV was 0.716, and for SWV was 0.765.
Significance
Greater spatial variability, particularly SWV, was associated with better motor skill of curved path walking. It is important for clinicians to understand the variables that contribute to successful performance of complex walking tasks as these can be targets for rehabilitation. The findings suggest that practice of adjustment of stride width and step length during walking are important.
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