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Vol. 68. Núm. 3.
Páginas 151-156 (Mayo - Junio 2017)
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Vol. 68. Núm. 3.
Páginas 151-156 (Mayo - Junio 2017)
Original article
DOI: 10.1016/j.otorri.2016.07.002
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Bone Anchored Hearing Aid (BAHA) in children: Experience of a tertiary referral centre in Portugal
Prótesis auditivas osteointegradas en niños: experiencia de un centro terciario de referencia en Portugal
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Francisco Rosa
Autor para correspondencia
franciscorosa97@gmail.com

Corresponding author.
, Ana Silva, Cláudia Reis, Miguel Coutinho, Jorge Oliveira, Cecília Almeida e Sousa
Department of Otorhinolaryngology, Head and Neck Surgery, Centro Hospitalar do Porto, Portugal
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Abstract
Objectives

The aim of this study is to describe the experience of a tertiary referral centre in Portugal, of the placement of BAHA in children.

Methods

The authors performed a retrospective analysis of all children for whom hearing rehabilitation with BAHA was indicated at a central hospital, between January 2003 and December 2014.

Results

53 children were included. The most common indications for placement of BAHA were external and middle ear malformations (n=34, 64%) and chronic otitis media with difficult to control otorrhea (n=9, 17%). The average age for BAHA placement was 10.66±3.44 years. The average audiometric gain was 31.5±7.20dB compared to baseline values, with average hearing threshold with BAHA of 19.6±5.79dB. The most frequent postoperative complications were related to the skin (n=15, 28%). There were no major complications.

Conclusions

This study concludes that BAHA is an effective and safe method of hearing rehabilitation in children.

Keywords:
Child
Hearing loss
Hearing aid
Bone conduction
Tertiary care centres
Resumen
Objetivos

El objetivo de este estudio es describir la experiencia de un centro terciario de referencia en Portugal, en la colocación de prótesis auditivas osteointegradas (BAHA) en los niños.

Métodos

Los autores realizaron un análisis retrospectivo de todos los niños con indicación para rehabilitación auditiva con BAHA en un hospital central, entre enero de 2003 y diciembre de 2014.

Resultados

Se incluyeron 53 niños. Las indicaciones más frecuentes para la colocación de BAHA fueron las malformaciones del oído externo y medio (n=34; 64%) y la otitis media crónica con otorrea de difícil control (n=9; 17%). La edad media de la colocación de BAHA fue de 10,66±3,44 años. La ganancia de audiometría promedio fue de 31,5±7,20dB en comparación con los valores basales, con un umbral medio de audición con BAHA de 19,6±5,79dB. Como complicaciones postoperatorias, las más frecuentes se relacionaron con la piel (n=15; 28%). No hubo complicaciones mayores.

Conclusiones

En este estudio se concluye que la BAHA es un método eficaz y seguro de rehabilitación auditiva en niños.

Palabras clave:
Niño
Hipoacusia
Audífono
Conducción ósea
Centros de atención terciaria
Texto completo
Introduction

In the hearing rehabilitation we face various pathologies and consequently different challenges. In certain pathologies or congenital malformations, hearing by air conduction is not feasible, so the bone conduction is the only way to restore hearing.

Tjellstrom, Swedish otolaryngologist and professor at Sahlgrenska University in Gothenburg, developed the concept of bone-anchored hearing aids (BAHA), having been the first results in adults presented in 1983.1

The BAHA system consists of a titanium implant placed surgically on the mastoid, fixed by bone integration process, and a percutaneous abutment, which fits the sound processor.2 This, captures the sound, processes it according to the individual needs and transforms it through the transducer in vibrations that are transmitted through direct bone conduction to the inner ear, without requiring the functional middle ear.

The use of bone-anchored hearing aids in children3,4 began in 1984 and since then hundreds of children in the world have already been operated.5

After 35 years of experience and more than 100,000 patients implanted worldwide, the BAHA, is now a universally accepted device for rehabilitation of adults and children with certain types of hearing loss.

In 1996 the Food and Drug Administration (FDA) allowed its use in the United States of America in cases of bilateral conductive or mixed hearing loss in adults.6

In 1999, the FDA extended its approval for use in children older than 5 years and in 2001 for bilateral implantation.7

After several years of research and development, patients with unilateral hearing loss, either of conduction or sensorineural, can now also benefit from this system, having the FDA approved this indication in 2002.8,9

The BAHA system does not affect the ear structures, so there is no risk of aggravating the hearing of the patient. Furthermore it is a reversible process if the patient does not adapt to it.10

The surgery can be performed in one or two surgical times, being the two surgical times procedure recommended for younger children.11

The sound processor is only adapted 2–4 months after surgery.12

Younger children or non-candidates for surgery may use conventional bone conduction hearing aid applied in stem glasses, headband or BAHA® Softband system in which the processor is set to the skull by an elastic band.

The high degree of satisfaction of rehabilitated patients with this system makes the BAHA a reliable method of success.7

The accurate selection of patients is critical to obtain good results, and the limitations of the equipment and the contraindications to its use must always be present.9

In Portugal, the first BAHA was placed in 2003 in our centre.9 Since then, this hospital has been the referral centre for the entire North region of Portugal. We have experienced most of the early and late stages of this rapidly developing technique. The aim of this study is to present our current experience of BAHA implantation in children, and to highlight the main indications, results and complications.

Material and methods

The authors performed a retrospective analysis of all children with indication for hearing rehabilitation with BAHA at a tertiary referral centre, between January 2003 and December 2014.

The study included patients younger than 18 years who underwent hearing rehabilitation with BAHA and at least one year of follow-up.

Exclusion criteria were: patients without audiometric evaluation or incomplete medical file.

The information was collected from medical records relating on age, gender, medical history, audiometry, clinical indications for placement of BAHA, as well as information about the surgery and its complications. All children included in the study performed preoperatively a CT scan of the temporal bone.

Hearing assessment was performed through pure tone audiometry, free field audiometry with and without the use of hearing aids.

The hearing loss is presented in pure tone average (PTA), determined by the average of pure tone thresholds of frequencies 500, 1000, 2000 and 4000Hz. Only the audiometric results obtained after 3 months of use of hearing aids were analyzed.

In the statistical analysis of data it was used the SPSS® Statistics 20.0 software.

Results

The present study evaluated 53 children: 26 (49%) were female and 27 (51%) male.

Fifty-two (99%) of these children, underwent auditory rehabilitation by BAHA and 1 (1%) by Softband.

All individuals were subjected to hearing rehabilitation as early as possible through conventional hearing aids. The use of these hearing aids began in average at 5 months of age.

Children rehabilitated with BAHA were submitted to a previous hearing test with Softband for documentation of the expected audiometric gains.

The mean age (±standard deviation) at the time of surgery was 10.66±3.44 years, between 4 years to 17 years (Fig. 1).

Figure 1.

Age distribution of patients undergoing surgery for the placement of BAHA.

(0,06MB).

Forty children (75%) were operated on the right side and thirteen children (25%) were operated on the left side. No child received bilateral BAHA.

In one case the patient was firstly implanted on the right side, but due to multiple local cutaneous complications was then implanted on the left side.

The most frequent indications for placing BAHA were malformations of the external and middle ear (n=34.64%), chronic otitis media (n=9.17%) and post-mastoidectomy status (n=7.13%).

In 3 cases (6%) the BAHA was placed for profound unilateral sensorineural hearing loss (Fig. 2).

Figure 2.

Indications for the placement of BAHA.

(0,06MB).

The external and middle ear malformations group includes several pathologies characterized by moderate to severe hearing loss, mixed or conductive: congenital aural atresia/agenesis, Apert syndrome, Goldenhar syndrome, Pierre-Robin syndrome, Sathre-Chotzen syndrome, Treacher-Collins syndrome, Turner's syndrome, Fanconi anaemia, bone dysplasia and other dysmorphic syndromes (Fig. 3).

Figure 3.

External and middle ear malformations.

(0,12MB).

Nine patients had chronic otitis media with recurrent otorrhea, thereby disturbing the adaptation of conventional hearing aids.

Patients described as post-mastoidectomy status, suffered from bilateral chronic otitis media with cholesteatoma, having been submitted to canal wall down mastoidectomy.

Among the 50 children with chronic inflammatory or malformative disorder of the middle ear, 17 (34%) had a cleft palate.

The three cases of unilateral profound sensorineural hearing loss were observed in school-age children (6, 11 and 12 years old).

One of the children had personal history of prematurity, low birth weight and family history of deafness; the other child suffered from perinatal hypoxia.

In this group one child did not have any significant personal or family history.

The placement of BAHA was performed in the majority of cases (N=40, 77%) in two different surgical times, with an average interval between procedures of 4.5±2.4 months.

Initially, the surgical technique contemplated the realization of a flap with the “U”-shape, using a dermatome, whose aim was to reduce the subcutaneous cellular tissue and thinning the flap. Currently our centre use a longitudinal incision (a modification of Nijmejen technique) without need for any type of flap, allowing a significant reduction in operative time. Although this technique is associated with a lower rate of complications in our study there was no significant difference.4,12

The average PTA in free field was 51.1±18.13dB and after BAHA placement was 19.6±5.79dB, which represented an average audiometric gain of 31.5±7.20dB.

After statistical analysis, with the paired sample t-test (p<0.05), statistically significant differences were found between the tonal values in free field without BAHA when compared with the values obtained with BAHA (Fig. 4).

Figure 4.

Audiometric gain with BAHA – paired sample t-test (p<0.05).

(0,07MB).

In the three cases of unilateral sensorineural hearing loss, the contralateral ear had a normal hearing.

In all cases, the subjective results were very satisfactory, with improvement in school performance.

For intraoperative complications just to mention a six-year-old child, with Pierre Robin syndrome, in which it was not possible to fix the implant, due to bone fragility. Therefore this child was rehabilitated with Softband with audiometric gain of 40dB relative to the base value (60dB).

As postoperative complications (Fig. 5), the most frequent ones were related to the skin reactions (n=15, 28%).

Figure 5.

Postoperative complications.

(0,09MB).

In ten cases (19%), skin changes were mild (Holgers classification13: 3 cases – Grade I; 4 cases – Grade II; 3 cases – Grade III) and satisfactorily solved with topical medical treatment (cream with an association of antibiotic and corticoid).

In the remaining five (9%), skin changes were more serious (grade IV – Holgers classification), requiring revision surgery: in two cases the was removed; in another one the abutment was removed and implanted in the contralateral side; in the last two cases a cutaneous intervention was held with efficient resolution of the pathology.

It is important to point out three cases (6%) of failure of osseointegration, and three cases in which it occurred extrusion of the implant by direct trauma. All these cases were readily solved with the placement of a new implant without further complications.

To note that one of the children, three years after the placement of BAHA, suffered a concussion during a football game with destruction of the BAHA processor without any other complications, so it was only necessary to adapt to a new processor.

Discussion

In the analyzed patients, and in accordance with international guidelines for paediatric BAHA, this surgery was performed only after 3 years of age.14,15

At the initial phase of the auditory rehabilitation programme with BAHA, our institution selected older children. However as the surgical experience increased children with progressively lower ages were operated.

In the study group, the main indications for placing BAHA were congenital malformations of the external and middle ear, and chronic inflammatory disease of the middle ear difficult to control.

These are classic indications for BAHA due to the difficulty or impossibility of adapting electroacoustic prostheses, representing groups in which the satisfaction ratings are higher.16

A fact to emphasize, is the high prevalence of cleft palate in our group, either associated with other malformations, or as an etiological factor of chronic otitis media.

In our sample, three children placed BAHA due to unilateral sensorineural hearing loss, which is an increasingly common indication, with benefits in eliminating the shadow effect and improved amplification in free-field.17

Niparko et al., 2003, compared the results with BAHA system and CROS system (Contralateral Routing Of Signals), the patients preferring the use of BAHA to the CROS system.18,19

To predict the benefit of their placement, all candidates for BAHA, underwent a test with Softband.

These must have a good cochlear reserve, with bone-conduction threshold below 45dB and discrimination above 60%.19

The dimension of the audiometric Rinne does not influence the indication, because this system performs a bypass of the middle and external ear.11

Most patients present in this study put the BAHA on the right side. The site of implantation was decided according to the thickness of the temporal bone, the laterality of the patient and degree of hearing loss in each ear. Before the surgical procedure, a CT scan of the temporal bone should be performed to assess the correct anatomy of the ear and the thickness of the cortical bone at the site where will be performed the implant.9,23

In selected cases, the BAHA is a very effective method of hearing rehabilitation.

The results of this study, with an average PTA in free-field with BAHA of 19.6±5.79dB, with an average audiometric gain of 31.5±7.20dB relative to baseline values, are similar to those found in other studies with children.20

The functional gains analyzed were very close to normal hearing, and the degree of satisfaction of patients and their caregivers very high.

This benefit is confirmed by the results published by Hol et al., 2005, in which 78% of patients referred to use the BAHA more than 8h per day.21

The main advantages of the BAHA over conventional hearing aids are: better amplification and sound quality, better bone conduction, comfort and aesthetic appearance, surgical procedure relatively simple, fast and with few complications.22

The option to perform surgery in a single or in two-time surgical procedure is a target issue of great debate, especially in patients in which general anaesthesia and intubation can be complicated.

However, the choice of two surgical times, spaced over a recommended period of 3–6 months allows a better bone integration of the titanium implant, allowing their application in increasingly younger ages. There are reports of BAHA successful placement in children with just 14 months old.23

In the presented study, the majority of BAHA (77%) was placed in two surgical procedures, in order to optimize the osseointegration of the titanium implant in the bone and to minimize the risk of extrusion, in a more theoretically susceptible population to traumas.

However as the surgical experience was increasing, younger and younger children were being successfully implanted in a single surgical procedure.

In our study, there were no major intraoperative complications. However the most common complications described in the literature are the bleeding in the site of implant placement and exposure of duramater with possible CSF fistula, occurring in less than 3% of cases.

These complications may limit the length of the implant but do not seem to influence the osseointegration.3

The most frequent postoperative complications (n=15, 28%) were cutaneous ones, especially grades I to III – Holgers classification, and these results are consistent with most studies.

To minimize this potential problem, patients should be educated about local hygiene techniques, sometimes requiring the use of topic antibiotics.24

In younger children, due to their greater dependence on parental care, the risk of such complications is bigger. In 10% (n=15) of the cases it was required a revision surgery for treatment of cutaneous complications. These figures are in line with most of the consulted series.25

The fact that the osseointegration of the implant has failed in three children is in accordance with recent studies indicating that the failure rate has a variation between 2.5% and 20%. The most frequent reasons for osseointegration failure are thin cortical bone, underlying pathology (e.g. Paget's disease), bad hygiene care and local infection.3,26

One of the inherent risks in the use of the BAHA is the possibility of the prosthesis destruction with or without extrusion of the implant, associated, for example, to trauma, as was it was the case with one of our children.

These risks can be significantly reduced through a psychological evaluation of the patient, teaching of postoperative care to children and their caregivers.

The BAHA extrusion occurs in 10% of the patients with one or more of the following reasons: late failure of osseointegration, trauma, infection or radiation.25

Despite successful treatment of these patient groups, there is always a need for future improvements. First, it is well known that BAHA are associated with some drawbacks related to skin infections, accidental or spontaneous loss of the bone implant, and patient refusal for treatment due to stigma.24 Therefore, some alternatives to the BAHA which have the potential to reduce these drawbacks have been developed. They all have the common feature that they do not need a permanent skin penetration. The alternatives to the BAHA are: (1) improved conventional bone conduction (BC) devices, (2) devices with an implanted transducer referred to as BC implants (BCI), (3) dental-attached devices. Recently, It has been developed an abutment-free bone-anchored hearing device, the BAHA Attract. This system can provide similar or higher output as compared with a BAHA, associated with a lower rate of complications.27

Conclusions

The surgical procedure of the BAHA is safe and easy to perform, with very low incidence of complications.

The BAHA system is an excellent option in the auditory rehabilitation of children with mixed or conductive hearing loss, and in cases of profound unilateral sensorineural hearing loss.

Financial support

This research received no specific grant from any funding agency, commercial or not-for-profit sectors.

Conflict of interests

None.

References
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Copyright © 2016. Elsevier España, S.L.U. and Sociedad Española de Otorrinolaringología y Cirugía de Cabeza y Cuello
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