**6.2.3 Broader outcomes of bilateral implantation**

Most of the research on outcomes for children with bilateral cochlear implants has focused on speech perception in noise and sound localization abilities. There is little research to date comparing broader outcomes of children with unilateral versus bilateral cochlear implants, and at the time of writing, there were no reports of speech production or academic outcomes. An initial theoretical analysis of the cost effectiveness of bilateral implantation suggested that it "is possibly a cost-effective use of resources", but that further data on the costs and benefits of bilateral implantation compared with unilateral implantation are required to reach a definitive conclusion (Summerfield et al., 2010). To date, two studies using standardized quality-of-life measures have attempted to determine whether bilateral implants facilitate improved quality of life in children, however neither reported a significant improvement for children with bilateral implants (Beijen, 2007; Lovett et al., 2010).

Information on the impact of bilateral cochlear implantation on language is currently limited. A recent study comparing the preverbal communication of children implanted before age 3 years (27 bilaterally; 42 unilaterally) reported that children with bilateral cochlear implants were significantly more likely to use vocalisation to communicate and to use hearing when interacting with an adult than were children with unilateral implants (Tait et al., 2010). After statistically controlling for the influence of age at implantation and length of deafness, it was found that bilateral implantation contributed to 51% of the variance in outcomes. A multi-center study of 91 children with unilateral (n=60) and bilateral (n=31) implants reported that bilateral implantation was not associated with improved expressive or receptive language development (Niparko et al., 2010). Similarly, Nittrouer & Chappman (2009) examined the vocabulary, receptive and expressive language abilities of 58 children tested at age 3.5 years and also found no differences in outcomes between 15 children with unilateral and 26 with bilateral cochlear implants. Both of these studies provide no support, in terms of language development, for providing young children with bilateral cochlear implants.

However, recent initial results of another prospective, multicentre study comparing outcomes for children with unilateral and bilateral cochlear implants showed a significant advantage for bilaterally implanted children with regard to language development (Sarant et al., in press). The groups of unilaterally (n= 11) and bilaterally (n=17) implanted 5-yearold children in this study did not differ with regard to average non-verbal cognitive ability,

Cochlear Implants in Children: A Review 363

implantation is a safe surgical procedure, and may also offer advantages to ease of adaptation, although there may be greater challenges associated with programming and

Outcomes with bilateral implants are influenced by many of the same interacting factors as with unilateral implants (see section 4). As with unilateral implants, factors such as age at time of first implant and amount of pre-operative auditory stimulation in the ear implanted second contribute to outcomes, with younger children and those with pre-implant hearing aid use achieving better results (Galvin et al., 2007a; Peters et al., 2007; Wolfe et al., 2007; Zeitler et al., 2008) . Consistency of device use also influences outcomes, with most children implanted at younger ages adapting more quickly and with greater ease to using bilateral implants, whether they are simultaneously or sequentially implanted (Galvin et al., 2008a; Scherf et al., 2009). Older sequentially implanted children and young adults (who are responsible for their own consistency of device use) must be highly self-motivated in order to persist with learning to use their second cochlear implant; this can be particularly difficult for children aged 7-12 years, especially if they have not been involved in the decisionmaking process (Galvin et al., 2009). Children implanted at younger ages are also more likely to achieve similar listening abilities with either device, and appear to have greater

For children implanted sequentially, greater improvements in speech perception and localization abilities are demonstrated when there is a shorter time period between the first and second implants (Galvin et al., 2008a; Schafer & Thibodeau, 2006). Factors associated with poor outcomes include poorer than expected outcomes with the first implant, a long time delay between the first and second implants, and limited experience and/or habilitation using the second implant on its own (Dowell et al., 2011). Given the limited information about outcomes for bilaterally implanted children to date, it is not currently

The early literature is limited in showing what is possible for bilaterally implanted children. Many studies have included children with very little experience at the time of assessment (as low as 6-12 months for many studies; Sparreboom et al., 2010). We know from the experience of both adults and children with unilateral implants that speech perception and other skills can improve over a period of years, and from bilateral studies that localization skills also require time to develop, therefore it is reasonable to expect that results could improve over time. The evidence is also limited in terms of the number of children who have been followed. A review of paediatric bilateral implant research noted that over half of the published studies reviewed had only 10 or fewer participants (Johnston et al., 2009). Although there are no reports to date on outcomes for children who have received bilateral cochlear implants aged under one year, it would not be unreasonable to expect that very early bilateral implantation would also further optimize outcomes, given the electrophysiological and other evidence collected to date (Peters et al., 2010). There is also currently a lack of evidence regarding quality of life, language, literacy and academic outcomes for children with bilateral compared to unilateral implants. As more children

managing two devices in younger children (Ramsden et al., 2009).

potential for the development of localization abilities.

possible to accurately predict outcomes for individuals.

**6.5 Limitations in current knowledge of outcomes with bilateral implants** 

**6.4 Factors affecting outcomes** 

parent involvement in intervention or parent stress levels, and children with bilateral cochlear implants achieved significantly higher expressive and total language scores than did children with unilateral cochlear implants. Initial results of a Belgian study of 25 bilaterally implanted children matched for 10 factors with 25 unilaterally implanted children also reported significantly better receptive and expressive language outcomes for the bilaterally implanted children (Boons et al., in press).

Considering other benefits of bilateral implants, Galvin and colleagues' research and clinical experience with older children and young adults indicates that there are more general benefits, such as ease of listening, awareness of the auditory environment, and increased confidence in social situations, that are of great functional value to children with bilateral implants (Galvin & Hughes, in press). For this group, self-motivation and external support and encouragement were particularly important, as adapting to a second implant at a later age is a more difficult process. Parent questionnaire data from this study for 38 children and young adults showed that 79% of children were using two cochlear implants more than 60% of the time, and 68% reported using bilateral implants more than 90% of the time. Reports of perceived benefit in everyday life also indicated that there was no upper age limit beyond which additional benefit could not be gained from bilateral implants. When considering the risks, time and effort required to obtain bilateral implants versus any additional benefit gained, 79% of the families reported that the second cochlear implant was worthwhile, 16% were unsure, and only 5% felt that obtaining bilateral implants had not been worthwhile (Karyn Galvin, personal communication, August 16th, 2011).

#### **6.3 Timing of first and second cochlear implants; sequential and simultaneous implantation**

It is reasonable to assume that children who receive a second cochlear implant early in life will have greater neural plasticity of the central auditory system, and that the first implant will have dominated the auditory neural pathways for a shorter period of time also. Electrophysiological studies of auditory brainstem responses in children with early onset of deafness support this view, showing prolonged wave latencies in the second implanted ear for children implanted sequentially compared to those implanted simultaneously (Gordon, 2008; Gordon et al., 2010). Follow up of children has shown that wave latencies improve over time, particularly for children implanted under 3 years of age (Gordon et al., 2007), and that cortical evoked responses are fundamentally different for children implanted before and after age 3.5 years in terms of wave morphology and latency (Bauer et al., 2006; Sharma et al., 2005). These studies suggest that the shortest delay possible (ie. simultaneous bilateral implantation) will maximise the chance of developing true binaural auditory processing. The clinical evidence reported to date supports the electrophysiological findings. Children who receive bilateral implants sequentially when younger adapt more quickly (Dowell et al., 2011; Galvin & Hughes, in press; Scherf et al., 2009) and generally have better speech perception and sound localization outcomes than those implanted when older (Galvin et al., 2007a).

 There appears to be a consensus that children receiving a second implant over the age of 4 years perform much more poorly on speech recognition and sound localization tasks, and do not show evidence of true binaural processing (for example, Galvin et al., 2007a; Johnston et al., 2009; Wolfe et al., 2007). Current evidence suggests that simultaneous bilateral

parent involvement in intervention or parent stress levels, and children with bilateral cochlear implants achieved significantly higher expressive and total language scores than did children with unilateral cochlear implants. Initial results of a Belgian study of 25 bilaterally implanted children matched for 10 factors with 25 unilaterally implanted children also reported significantly better receptive and expressive language outcomes for the

Considering other benefits of bilateral implants, Galvin and colleagues' research and clinical experience with older children and young adults indicates that there are more general benefits, such as ease of listening, awareness of the auditory environment, and increased confidence in social situations, that are of great functional value to children with bilateral implants (Galvin & Hughes, in press). For this group, self-motivation and external support and encouragement were particularly important, as adapting to a second implant at a later age is a more difficult process. Parent questionnaire data from this study for 38 children and young adults showed that 79% of children were using two cochlear implants more than 60% of the time, and 68% reported using bilateral implants more than 90% of the time. Reports of perceived benefit in everyday life also indicated that there was no upper age limit beyond which additional benefit could not be gained from bilateral implants. When considering the risks, time and effort required to obtain bilateral implants versus any additional benefit gained, 79% of the families reported that the second cochlear implant was worthwhile, 16% were unsure, and only 5% felt that obtaining bilateral implants had not been worthwhile

bilaterally implanted children (Boons et al., in press).

(Karyn Galvin, personal communication, August 16th, 2011).

**implantation** 

2007a).

**6.3 Timing of first and second cochlear implants; sequential and simultaneous** 

It is reasonable to assume that children who receive a second cochlear implant early in life will have greater neural plasticity of the central auditory system, and that the first implant will have dominated the auditory neural pathways for a shorter period of time also. Electrophysiological studies of auditory brainstem responses in children with early onset of deafness support this view, showing prolonged wave latencies in the second implanted ear for children implanted sequentially compared to those implanted simultaneously (Gordon, 2008; Gordon et al., 2010). Follow up of children has shown that wave latencies improve over time, particularly for children implanted under 3 years of age (Gordon et al., 2007), and that cortical evoked responses are fundamentally different for children implanted before and after age 3.5 years in terms of wave morphology and latency (Bauer et al., 2006; Sharma et al., 2005). These studies suggest that the shortest delay possible (ie. simultaneous bilateral implantation) will maximise the chance of developing true binaural auditory processing. The clinical evidence reported to date supports the electrophysiological findings. Children who receive bilateral implants sequentially when younger adapt more quickly (Dowell et al., 2011; Galvin & Hughes, in press; Scherf et al., 2009) and generally have better speech perception and sound localization outcomes than those implanted when older (Galvin et al.,

 There appears to be a consensus that children receiving a second implant over the age of 4 years perform much more poorly on speech recognition and sound localization tasks, and do not show evidence of true binaural processing (for example, Galvin et al., 2007a; Johnston et al., 2009; Wolfe et al., 2007). Current evidence suggests that simultaneous bilateral implantation is a safe surgical procedure, and may also offer advantages to ease of adaptation, although there may be greater challenges associated with programming and managing two devices in younger children (Ramsden et al., 2009).

#### **6.4 Factors affecting outcomes**

Outcomes with bilateral implants are influenced by many of the same interacting factors as with unilateral implants (see section 4). As with unilateral implants, factors such as age at time of first implant and amount of pre-operative auditory stimulation in the ear implanted second contribute to outcomes, with younger children and those with pre-implant hearing aid use achieving better results (Galvin et al., 2007a; Peters et al., 2007; Wolfe et al., 2007; Zeitler et al., 2008) . Consistency of device use also influences outcomes, with most children implanted at younger ages adapting more quickly and with greater ease to using bilateral implants, whether they are simultaneously or sequentially implanted (Galvin et al., 2008a; Scherf et al., 2009). Older sequentially implanted children and young adults (who are responsible for their own consistency of device use) must be highly self-motivated in order to persist with learning to use their second cochlear implant; this can be particularly difficult for children aged 7-12 years, especially if they have not been involved in the decisionmaking process (Galvin et al., 2009). Children implanted at younger ages are also more likely to achieve similar listening abilities with either device, and appear to have greater potential for the development of localization abilities.

For children implanted sequentially, greater improvements in speech perception and localization abilities are demonstrated when there is a shorter time period between the first and second implants (Galvin et al., 2008a; Schafer & Thibodeau, 2006). Factors associated with poor outcomes include poorer than expected outcomes with the first implant, a long time delay between the first and second implants, and limited experience and/or habilitation using the second implant on its own (Dowell et al., 2011). Given the limited information about outcomes for bilaterally implanted children to date, it is not currently possible to accurately predict outcomes for individuals.

### **6.5 Limitations in current knowledge of outcomes with bilateral implants**

The early literature is limited in showing what is possible for bilaterally implanted children. Many studies have included children with very little experience at the time of assessment (as low as 6-12 months for many studies; Sparreboom et al., 2010). We know from the experience of both adults and children with unilateral implants that speech perception and other skills can improve over a period of years, and from bilateral studies that localization skills also require time to develop, therefore it is reasonable to expect that results could improve over time. The evidence is also limited in terms of the number of children who have been followed. A review of paediatric bilateral implant research noted that over half of the published studies reviewed had only 10 or fewer participants (Johnston et al., 2009). Although there are no reports to date on outcomes for children who have received bilateral cochlear implants aged under one year, it would not be unreasonable to expect that very early bilateral implantation would also further optimize outcomes, given the electrophysiological and other evidence collected to date (Peters et al., 2010). There is also currently a lack of evidence regarding quality of life, language, literacy and academic outcomes for children with bilateral compared to unilateral implants. As more children

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receive bilateral implants, studies with larger numbers of participants observed over longer periods of time will be conducted, as has occurred with unilateral implants. These studies will no doubt provide further information on which the magnitude of the effect of bilateral implants on outcomes can be measured.

#### **7. Conclusion**

Enormous progress has been made over the past three decades in the development of cochlear implants. We have progressed from uncertainty and controversy around whether children could use the incomplete auditory information provided by a unilateral cochlear implant to develop spoken language, to documenting outstanding and life-transforming success for many children with unilateral or bilateral cochlear implants. Cochlear implants are now accepted as the standard of care for children with severe-profound hearing loss. They have allowed many children to attend regular schools, and to develop their language, social and academic skills to levels that exceed those for their peers with severe-profound hearing loss using hearing aids. For some children, cochlear implants have facilitated outcomes such as those their hearing peers achieve, including post-secondary school study, fulfilling employment, and rich social relationships in the hearing world. However, there are still a significant number of children with cochlear implants whose speech intelligibility, speech perception, spoken language, academic and social development are far below that of children with normal hearing. There remains enormous variation in outcomes between individuals with both unilateral and bilateral cochlear implants. Other influences related to neural maturation and development, and also to complex interactions between demographic variables, environmental factors, intervention and learning processes, are not yet understood. A challenge for the future will be to make progress in our understanding of these factors and processes in order to improve outcomes for a greater proportion of children with cochlear implants. Further follow-up of children with unilateral and bilateral cochlear implants is required in the future to determine what the best outcomes will be.

#### **8. References**


receive bilateral implants, studies with larger numbers of participants observed over longer periods of time will be conducted, as has occurred with unilateral implants. These studies will no doubt provide further information on which the magnitude of the effect of bilateral

Enormous progress has been made over the past three decades in the development of cochlear implants. We have progressed from uncertainty and controversy around whether children could use the incomplete auditory information provided by a unilateral cochlear implant to develop spoken language, to documenting outstanding and life-transforming success for many children with unilateral or bilateral cochlear implants. Cochlear implants are now accepted as the standard of care for children with severe-profound hearing loss. They have allowed many children to attend regular schools, and to develop their language, social and academic skills to levels that exceed those for their peers with severe-profound hearing loss using hearing aids. For some children, cochlear implants have facilitated outcomes such as those their hearing peers achieve, including post-secondary school study, fulfilling employment, and rich social relationships in the hearing world. However, there are still a significant number of children with cochlear implants whose speech intelligibility, speech perception, spoken language, academic and social development are far below that of children with normal hearing. There remains enormous variation in outcomes between individuals with both unilateral and bilateral cochlear implants. Other influences related to neural maturation and development, and also to complex interactions between demographic variables, environmental factors, intervention and learning processes, are not yet understood. A challenge for the future will be to make progress in our understanding of these factors and processes in order to improve outcomes for a greater proportion of children with cochlear implants. Further follow-up of children with unilateral and bilateral cochlear implants is required in the future to determine what the best outcomes will be.

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**16** 

*Tunisia* 

**Intratympanic Corticosteroid** 

**for Neurosensorial Hearing Loss Treatment** 

Adel Chakroun, Ilheme Charfeddine and Abdelmonem Ghorbel *Department of ENT and Head Neck Surgery, CHU Habib Bourguiba, Sfax* 

The application of drugs through the eardrum and into the middle ear to treat various otologic disorders, such as Meniere's disease and sudden sensorineural hearing loss has recently gained widespread popularity. The intratympanic treatment modality can provide also a chemoprotection strategy for exposure to noise (1) cisplatin (2), and aminoglycosides

Inflammatory processes may play a role in the etiology of various inner ear pathologies of which the pathogenesis is poorly understood. Intratymapanic corticosteroid may be a

Neurosensorial hearing loss therapy to date has consisted mostly of the systemic administration of steroids and has been limited by their side effects and low therapeutic concentrations within the fluids and tissues of the inner ear. It has been shown in animals and humans that systemically applied glucocorticoids reach only low drug concentrations in the perilymph. The local application of drugs to treat inner ear diseases is expected to provide advantages as compared with systemic treatments, namely: 1) bypassing the bloodlabyrinthine barrier, 2) resulting in higher concentrations in the inner ear fluids 3) avoiding

Despite some successes, the local medical treatment of inner ear conditions, is often frustrating to patients and physicians. We review the status of the intratympanic

The delivery of medications to the inner ear through the transtympanic route dates back to 1935, when Barany (4) used intratympanic lidocaine for treatment of tinnitus. Since then, other molecules have been used and the indications have expanded. In 1948, streptomycin was used to treat patients with unilateral Meniere's disease specifically on the basis of its vestibulotoxic effects (5). It was Harold Schuknecht who proposed the use of streptomycin as an alternative to surgical unilateral labyrinthine ablation (6). Francis Bauer, in 1969 and 1971 reported on the treatment of "Glue Ear" by using intratympanic urea (7). Another

**1. Introduction** 

corticosteroids treatment.

**2. History** 

promising therapy for several ear disorders.

major unwanted effects of systemically administered medications.

(3).

Malek Mnejja, Bouthaina Hammami, Amine Chakroun,

