International Journal of Pediatric Otorhinolaryngology 78 (2014) 232–234
Contents lists available at ScienceDirect
International Journal of Pediatric Otorhinolaryngology journal homepage: www.elsevier.com/locate/ijporl
Bone-anchored hearing aid: Why do some patients refuse it?§ Faisal Zawawi, Ghassan Kabbach, Marie Lallemand, Sam J. Daniel * Department of Otolaryngology – Head and Neck Surgery, McGill University, Montreal, QC, Canada
A R T I C L E I N F O
A B S T R A C T
Article history: Received 31 August 2013 Received in revised form 8 November 2013 Accepted 9 November 2013 Available online 18 November 2013
Objective: Bone-anchored hearing aid (BAHATM) is a proven tool to improve hearing. Nevertheless, there are patients who are candidates for BAHATM implants that end up refusing the surgery. The objective of this study is to review our BAHATM experience with particular emphasis on reasons behind the refusal of some candidates. Methods: A prospective cohort of 100 consecutive new candidates referred to The BAHATM program in a tertiary health care center. Candidates’ demographics, hearing status, Co-morbidities and audiometeric tests were all recorded. Patients’ acceptance or refusal was noted alongside the reasons to refuse BAHATM. Results: 100 new candidates were seen for BAHATM assessment, 10 patients were excluded due to incomplete data. There were 68 children and 22 adults. Unilateral Conductive Hearing Loss was the most common reason for consultation (40%), followed by unilateral SNHL (23.3%). Aural Atresia was the commonest clinical finding (36.6%). The commonest reason for refusal was social acceptance by the parents due to concern with cosmesis. Conclusion: The main reason of BAHATM surgery refusal, in otherwise eligible candidates, is related to cosmesis. Patients with congenital anomalies were the most likely candidates to accept BAHATM implants. ß 2013 Published by Elsevier Ireland Ltd.
Keywords: BAHA Hearing loss Candidacy Cosmetic
1. Introduction Bone-anchored hearing aid (BAHATM) is a surgically implantable system for the treatment of certain types of conductive and mixed hearing loss. It works through direct bone conduction [1]. It provides a high quality sound transmission with sufficient quality and gain thanks to the percutaneous and direct vibration transmission through the titanium implant anchored on to the skull bone. The technology was initially discovered in Sweden in the 1960s. Branemark et al, described that osseointegration that lead the way to development of various percutaneous titanium implants [2]. It did not take long until this technology was applied to improve hearing [3]. BAHATM implantable devices became commercially available in 1987 [4], but it was not until the late 1990s when BAHATM was cleared by FDA for the treatment of conductive and mixed hearing loss. In 2002 FDA approved it for treatment of unilateral SNHL [5].
§ This study was presented as a poster in the American Academy of Otolaryngology–Head and Neck surgery annual meeting in Washington, DC. September 2012. * Corresponding author at: Department of Otolaryngology, Montreal Children’s Hospital, 2300 rue Tupper, B-240, Montreal, QC H3H 1P3, Canada. Tel.: +1 514 412 4246. E-mail address: [email protected] (S.J. Daniel).
0165-5876/$ – see front matter ß 2013 Published by Elsevier Ireland Ltd. http://dx.doi.org/10.1016/j.ijporl.2013.11.010
BAHATM is very helpful in patients with congenital ear atresia, chronic ear infection, open mastoid cavity and single sided deafness patients who cannot benefit from conventional hearing aids [6]. Despite its well established benefits there are still patients referred for BAHATM implant that refuse to undergo this surgery. The reasons for this are variable. The objective of this study was to review a prospective cohort of consecutive BAHATM candidates referred to the senior author in order to identify reasons of BAHATM refusal by some candidates. 2. Methods and materials A prospective cohort of 100 consecutive new candidates referred to the BAHATM program at 2 McGill University affiliated hospitals. This study was approved by the McGill University Heath Center institutional review board. Data available included demographics, hearing status, comorbidities, audiometric tests and the reason of surgery refusal by some of the good candidates. Descriptive statistics were applied to characterize the demographics, diagnosis and hearing condition of patients. Candidacy was established based on audiological testing that identified patients who would benefit from bone-anchored hearing aid, whether it was unilateral hearing loss or bilateral mixed or
F. Zawawi et al. / International Journal of Pediatric Otorhinolaryngology 78 (2014) 232–234 Table 1 Audiological diagnosis of referred candidates to our BAHATM program. Hearing loss
Accepted BAHATM
Refused BAHATM
Total
Unilateral CHL Unilateral SNHL Bilateral CHL Bilateral mixed Hearing loss Other Total
33 16 17 8 6 80
3 5 2 0 0 10
36 21 19 8 6 90
CHL. Patients with bilateral SNHL, or severe mixed hearing loss were not considered candidates. Additionally, patients had to be medically fit to undergo surgery and motivated to care for their implant. 3. Results Out of 100 candidates, 10 were excluded due to incomplete data. There were 68 Children and 22 Adults. The most common cause for referral was unilateral conductive hearing loss n = 36, followed by unilateral sensorineural hearing loss n = 21, and bilateral conductive hearing loss n = 19 (Table 1). Aural atresia was the most common congenital anomaly n = 32. Several of the patients included in this study were syndromic. Syndromes included trisomy 21, Treacher Collin’s, Craniofacial Microsomia, Dandy-Walker, Pfierfer’s, and Nager’s. 11% of BAHATM candidates (n = 10) refused implantation despite satisfactory preoperative audiometeric studies. These were 2 adults and 8 parents of children. Overall the most common reason for refusal was related to cosmetic concerns (n = 6). Two patients did not feel significant improvement in their quality of life, 1 refused it for dissatisfaction with sound localization and 1 family for perceived future coping difficulties (Table 2). The most common audiological diagnosis in patients who refused BAHATM was unilateral SNHL (Table 1). 4. Discussion BAHATM is a well-established device to assist patients with various causes of hearing loss [7]. The fact that some patients and families refuse implantation warrants revisiting the counseling process. In the pediatric population, our review showed a considerable concern regarding cosmesis and social acceptance and this was in fact the main reason of refusal by the families. It has been reported that 76% patients found BAHATM implants to be discrete [8]. Additionally, studies in the literature note that up to 19% of implanted patients found BAHATM to be less appealing socially [8]. BAHATM has been reported to improve up to 80% of the implanted patients’ quality of life [9]. As with any other medical and surgical interventions, it requires appropriate selection and perioperative patients’ counseling. Careful attention to patients’ needs and concerns will aid in patients selections. The serior author (S.D) follows a rigorous protocol whereby all referred patients after passing a detailed audiological candidacy assessment get a loaner headband implant to test the benefit in Table 2 Reasons of surgery refusal by BAHATM candidates. Reason
N
Social acceptance/cosmetics No significant quality of life benefit Lack of sound localization Other medical reasons
6 2 1 1
233
different environments; e.g. Work, home and school. In our experience, this has been a tremendous help in preoperative patients counseling and selection. This has been particularly helpful to one of the candidates involved in this study that was seeking BAHATM as a solution to his unilateral SNHL. This particular patient is blind and his main concern was to be able to cross the street safely. The patient realized after using the headband that implanting the BAHATM will not help him localize sounds. To date none of the BAHATM implanted patients in this cohort have been explanted, and all are active users of their device. We believe that giving the patients the chance to test the BAHATM in their own environment, using a headband loaner, plays a major role in their ability to understand the benefit of BAHATM. In the group studied in this paper, the skin hygiene and crusting was not a deciding factor in refusing the implant. The patients and their families accepted this potential risk in the presence of hearing improvement. Interestingly, the most common audiological diagnosis of patients refusing implantation was unilateral SNHL. Although the sample size is low, a trend is noted in that 50% of those who refused BAHATM implantation suffered from SNHL, while the most common diagnosis in BAHATM candidates was unilateral CHL. It appears that in some patients with unilateral SNHHL, the improvement in quality of life and hearing did not outweigh the cosmetic drawback. Several new devices that address cosmetic concerns raised by patients and families are surfacing. An example is the intra-oral bone conduction device that is currently licensed for adult use only (e.g. SoundBiteTM). Other devices rely on transcutaneous magnetic stimulation (e.g. SophonoTM). While these devices have the potential of addressing the most common reason for BAHATM refusal, we currently do not have enough data on audiological and quality of life improvement in comparison with BAHATM. In theory, the transcutaneous devices may produce a lower sound amplification in comparison to the implantable abutment devices (e.g. BAHATM). Also, some of these devices use magnet technology, which has its own drawbacks and limitations especially for patients requiring frequent radiological examination [10]. Future studies should focus on comparing the audiological benefits between BAHATM and the new devices that can potentially be offered to patients who refuse BAHATM due to concern with cosmesis. 5. Conclusion Screening and counseling patients prior to BAHATM implantation is an essential step that addresses concerns that may lead to unsatisfactory results. In our study the main reason for refusal was cosmetic and social acceptance. Future advancement should focus on addressing these concerns without loosing the sound amplification quality. Funding No funding was necessary for this work. References [1] A. van Wieringen, K. De Voecht, A.J. Bosman, J. Wouters, Functional benefit of the bone-anchored hearing aid with different auditory profiles: objective and subjective measures, Clin. Otolaryngol. 36 (2011) 114–120. [2] P.I. Branemark, R. Adell, U. Breine, B.O. Hansson, J. Lindstrom, A. Ohlsson, Intraosseous anchorage of dental prostheses. I. Experimental studies, Scand. J. Plast. Reconstr. Surg. 3 (1969) 81–100. [3] T. Albrektsson, P.I. Branemark, H.A. Hansson, J. Lindstrom, Osseointegrated titanium implants. Requirements for ensuring a long-lasting, direct bone-to-implant anchorage in man, Acta Orthop. 52 (1981) 155–170. [4] B.E. Hakansson, P.U. Carlsson, A. Tjellstrom, G. Liden, The bone-anchored hearing aid: principal design and audiometric results, Ear Nose Throat J. 73 (1994) 670–675.
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F. Zawawi et al. / International Journal of Pediatric Otorhinolaryngology 78 (2014) 232–234
[5] A. Hagr, BAHA: bone-anchored hearing aid, Int. J. Health Sci. 1 (2007) 265–276. [6] S. Roman, R. Nicollas, J.M. Triglia, Practice guidelines for bone-anchored hearing aids in children, Eur. Ann. Otorhinolaryngol. Head Neck Dis. 128 (2011) 253–258. [7] A. Tjellstrom, J. Lindstrom, O. Hallen, T. Albrektsson, P.I. Branemark, Osseointegrated titanium implants in the temporal bone. A clinical study on bone-anchored hearing aids, Am. J. Otol. 2 (1981) 304–310. [8] J. Rasmussen, S.O. Olsen, L.H. Nielsen, Evaluation of long-term patient satisfaction and experience with the Baha(R) bone conduction implant, Int. J. Audiol. 51 (2012) 194–199.
[9] N. Saroul, L. Gilain, A. Montalban, F. Giraudet, P. Avan, T. Mom, Patient satisfaction and functional results with the bone-anchored hearing aid (BAHA), Eur. Ann. Otorhinolaryngol. Head Neck Dis. 128 (2011) 107– 113. [10] M.K. Hol, R.C. Nelissen, M.J. Agterberg, C.W. Cremers, A.F. Snik, Comparison between a new implantable transcutaneous bone conductor and percutaneous bone-conduction hearing implant, Otol. Neurotol. 34 (6) (2013) 1071– 1075.
Contents lists available at ScienceDirect
International Journal of Pediatric Otorhinolaryngology journal homepage: www.elsevier.com/locate/ijporl
Bone-anchored hearing aid: Why do some patients refuse it?§ Faisal Zawawi, Ghassan Kabbach, Marie Lallemand, Sam J. Daniel * Department of Otolaryngology – Head and Neck Surgery, McGill University, Montreal, QC, Canada
A R T I C L E I N F O
A B S T R A C T
Article history: Received 31 August 2013 Received in revised form 8 November 2013 Accepted 9 November 2013 Available online 18 November 2013
Objective: Bone-anchored hearing aid (BAHATM) is a proven tool to improve hearing. Nevertheless, there are patients who are candidates for BAHATM implants that end up refusing the surgery. The objective of this study is to review our BAHATM experience with particular emphasis on reasons behind the refusal of some candidates. Methods: A prospective cohort of 100 consecutive new candidates referred to The BAHATM program in a tertiary health care center. Candidates’ demographics, hearing status, Co-morbidities and audiometeric tests were all recorded. Patients’ acceptance or refusal was noted alongside the reasons to refuse BAHATM. Results: 100 new candidates were seen for BAHATM assessment, 10 patients were excluded due to incomplete data. There were 68 children and 22 adults. Unilateral Conductive Hearing Loss was the most common reason for consultation (40%), followed by unilateral SNHL (23.3%). Aural Atresia was the commonest clinical finding (36.6%). The commonest reason for refusal was social acceptance by the parents due to concern with cosmesis. Conclusion: The main reason of BAHATM surgery refusal, in otherwise eligible candidates, is related to cosmesis. Patients with congenital anomalies were the most likely candidates to accept BAHATM implants. ß 2013 Published by Elsevier Ireland Ltd.
Keywords: BAHA Hearing loss Candidacy Cosmetic
1. Introduction Bone-anchored hearing aid (BAHATM) is a surgically implantable system for the treatment of certain types of conductive and mixed hearing loss. It works through direct bone conduction [1]. It provides a high quality sound transmission with sufficient quality and gain thanks to the percutaneous and direct vibration transmission through the titanium implant anchored on to the skull bone. The technology was initially discovered in Sweden in the 1960s. Branemark et al, described that osseointegration that lead the way to development of various percutaneous titanium implants [2]. It did not take long until this technology was applied to improve hearing [3]. BAHATM implantable devices became commercially available in 1987 [4], but it was not until the late 1990s when BAHATM was cleared by FDA for the treatment of conductive and mixed hearing loss. In 2002 FDA approved it for treatment of unilateral SNHL [5].
§ This study was presented as a poster in the American Academy of Otolaryngology–Head and Neck surgery annual meeting in Washington, DC. September 2012. * Corresponding author at: Department of Otolaryngology, Montreal Children’s Hospital, 2300 rue Tupper, B-240, Montreal, QC H3H 1P3, Canada. Tel.: +1 514 412 4246. E-mail address: [email protected] (S.J. Daniel).
0165-5876/$ – see front matter ß 2013 Published by Elsevier Ireland Ltd. http://dx.doi.org/10.1016/j.ijporl.2013.11.010
BAHATM is very helpful in patients with congenital ear atresia, chronic ear infection, open mastoid cavity and single sided deafness patients who cannot benefit from conventional hearing aids [6]. Despite its well established benefits there are still patients referred for BAHATM implant that refuse to undergo this surgery. The reasons for this are variable. The objective of this study was to review a prospective cohort of consecutive BAHATM candidates referred to the senior author in order to identify reasons of BAHATM refusal by some candidates. 2. Methods and materials A prospective cohort of 100 consecutive new candidates referred to the BAHATM program at 2 McGill University affiliated hospitals. This study was approved by the McGill University Heath Center institutional review board. Data available included demographics, hearing status, comorbidities, audiometric tests and the reason of surgery refusal by some of the good candidates. Descriptive statistics were applied to characterize the demographics, diagnosis and hearing condition of patients. Candidacy was established based on audiological testing that identified patients who would benefit from bone-anchored hearing aid, whether it was unilateral hearing loss or bilateral mixed or
F. Zawawi et al. / International Journal of Pediatric Otorhinolaryngology 78 (2014) 232–234 Table 1 Audiological diagnosis of referred candidates to our BAHATM program. Hearing loss
Accepted BAHATM
Refused BAHATM
Total
Unilateral CHL Unilateral SNHL Bilateral CHL Bilateral mixed Hearing loss Other Total
33 16 17 8 6 80
3 5 2 0 0 10
36 21 19 8 6 90
CHL. Patients with bilateral SNHL, or severe mixed hearing loss were not considered candidates. Additionally, patients had to be medically fit to undergo surgery and motivated to care for their implant. 3. Results Out of 100 candidates, 10 were excluded due to incomplete data. There were 68 Children and 22 Adults. The most common cause for referral was unilateral conductive hearing loss n = 36, followed by unilateral sensorineural hearing loss n = 21, and bilateral conductive hearing loss n = 19 (Table 1). Aural atresia was the most common congenital anomaly n = 32. Several of the patients included in this study were syndromic. Syndromes included trisomy 21, Treacher Collin’s, Craniofacial Microsomia, Dandy-Walker, Pfierfer’s, and Nager’s. 11% of BAHATM candidates (n = 10) refused implantation despite satisfactory preoperative audiometeric studies. These were 2 adults and 8 parents of children. Overall the most common reason for refusal was related to cosmetic concerns (n = 6). Two patients did not feel significant improvement in their quality of life, 1 refused it for dissatisfaction with sound localization and 1 family for perceived future coping difficulties (Table 2). The most common audiological diagnosis in patients who refused BAHATM was unilateral SNHL (Table 1). 4. Discussion BAHATM is a well-established device to assist patients with various causes of hearing loss [7]. The fact that some patients and families refuse implantation warrants revisiting the counseling process. In the pediatric population, our review showed a considerable concern regarding cosmesis and social acceptance and this was in fact the main reason of refusal by the families. It has been reported that 76% patients found BAHATM implants to be discrete [8]. Additionally, studies in the literature note that up to 19% of implanted patients found BAHATM to be less appealing socially [8]. BAHATM has been reported to improve up to 80% of the implanted patients’ quality of life [9]. As with any other medical and surgical interventions, it requires appropriate selection and perioperative patients’ counseling. Careful attention to patients’ needs and concerns will aid in patients selections. The serior author (S.D) follows a rigorous protocol whereby all referred patients after passing a detailed audiological candidacy assessment get a loaner headband implant to test the benefit in Table 2 Reasons of surgery refusal by BAHATM candidates. Reason
N
Social acceptance/cosmetics No significant quality of life benefit Lack of sound localization Other medical reasons
6 2 1 1
233
different environments; e.g. Work, home and school. In our experience, this has been a tremendous help in preoperative patients counseling and selection. This has been particularly helpful to one of the candidates involved in this study that was seeking BAHATM as a solution to his unilateral SNHL. This particular patient is blind and his main concern was to be able to cross the street safely. The patient realized after using the headband that implanting the BAHATM will not help him localize sounds. To date none of the BAHATM implanted patients in this cohort have been explanted, and all are active users of their device. We believe that giving the patients the chance to test the BAHATM in their own environment, using a headband loaner, plays a major role in their ability to understand the benefit of BAHATM. In the group studied in this paper, the skin hygiene and crusting was not a deciding factor in refusing the implant. The patients and their families accepted this potential risk in the presence of hearing improvement. Interestingly, the most common audiological diagnosis of patients refusing implantation was unilateral SNHL. Although the sample size is low, a trend is noted in that 50% of those who refused BAHATM implantation suffered from SNHL, while the most common diagnosis in BAHATM candidates was unilateral CHL. It appears that in some patients with unilateral SNHHL, the improvement in quality of life and hearing did not outweigh the cosmetic drawback. Several new devices that address cosmetic concerns raised by patients and families are surfacing. An example is the intra-oral bone conduction device that is currently licensed for adult use only (e.g. SoundBiteTM). Other devices rely on transcutaneous magnetic stimulation (e.g. SophonoTM). While these devices have the potential of addressing the most common reason for BAHATM refusal, we currently do not have enough data on audiological and quality of life improvement in comparison with BAHATM. In theory, the transcutaneous devices may produce a lower sound amplification in comparison to the implantable abutment devices (e.g. BAHATM). Also, some of these devices use magnet technology, which has its own drawbacks and limitations especially for patients requiring frequent radiological examination [10]. Future studies should focus on comparing the audiological benefits between BAHATM and the new devices that can potentially be offered to patients who refuse BAHATM due to concern with cosmesis. 5. Conclusion Screening and counseling patients prior to BAHATM implantation is an essential step that addresses concerns that may lead to unsatisfactory results. In our study the main reason for refusal was cosmetic and social acceptance. Future advancement should focus on addressing these concerns without loosing the sound amplification quality. Funding No funding was necessary for this work. References [1] A. van Wieringen, K. De Voecht, A.J. Bosman, J. Wouters, Functional benefit of the bone-anchored hearing aid with different auditory profiles: objective and subjective measures, Clin. Otolaryngol. 36 (2011) 114–120. [2] P.I. Branemark, R. Adell, U. Breine, B.O. Hansson, J. Lindstrom, A. Ohlsson, Intraosseous anchorage of dental prostheses. I. Experimental studies, Scand. J. Plast. Reconstr. Surg. 3 (1969) 81–100. [3] T. Albrektsson, P.I. Branemark, H.A. Hansson, J. Lindstrom, Osseointegrated titanium implants. Requirements for ensuring a long-lasting, direct bone-to-implant anchorage in man, Acta Orthop. 52 (1981) 155–170. [4] B.E. Hakansson, P.U. Carlsson, A. Tjellstrom, G. Liden, The bone-anchored hearing aid: principal design and audiometric results, Ear Nose Throat J. 73 (1994) 670–675.
234
F. Zawawi et al. / International Journal of Pediatric Otorhinolaryngology 78 (2014) 232–234
[5] A. Hagr, BAHA: bone-anchored hearing aid, Int. J. Health Sci. 1 (2007) 265–276. [6] S. Roman, R. Nicollas, J.M. Triglia, Practice guidelines for bone-anchored hearing aids in children, Eur. Ann. Otorhinolaryngol. Head Neck Dis. 128 (2011) 253–258. [7] A. Tjellstrom, J. Lindstrom, O. Hallen, T. Albrektsson, P.I. Branemark, Osseointegrated titanium implants in the temporal bone. A clinical study on bone-anchored hearing aids, Am. J. Otol. 2 (1981) 304–310. [8] J. Rasmussen, S.O. Olsen, L.H. Nielsen, Evaluation of long-term patient satisfaction and experience with the Baha(R) bone conduction implant, Int. J. Audiol. 51 (2012) 194–199.
[9] N. Saroul, L. Gilain, A. Montalban, F. Giraudet, P. Avan, T. Mom, Patient satisfaction and functional results with the bone-anchored hearing aid (BAHA), Eur. Ann. Otorhinolaryngol. Head Neck Dis. 128 (2011) 107– 113. [10] M.K. Hol, R.C. Nelissen, M.J. Agterberg, C.W. Cremers, A.F. Snik, Comparison between a new implantable transcutaneous bone conductor and percutaneous bone-conduction hearing implant, Otol. Neurotol. 34 (6) (2013) 1071– 1075.
