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1. Introduction
Hearing loss is a prevalent disorder among infants and toddlers. The average incidence rate of hearing loss in newborns in the USA  is approximately 1.1 per 1000 infants [1]. This prevalence is higher in infants suffering from one or more risk factors for hearing impairment. The prevalence of hearing loss in neonates with low risk extends from 0.09% to 2.3%; however, in the high-risk infants, it is estimated to range from 0.3% to 14.1%. The prevalence rate of hearing loss is as high as 11% in neonates with very low birth weight [2].  Iran lacks a nationwide estimation about hearing loss prevalence; however,  based on some studies, it seems to be highly prevalent especially due to the high rate of consanguinity in Iran [3, 4]. 
The severity of hearing loss can range from mild to profound and can be monaural or bilateral. Hearing loss, in general, has adverse effects on speech and language development. The negative consequences of hearing loss increase with the severity of hearing loss, the involvement of both ears, and prelingual hearing loss [5, 6]. The first three years of infant’s life (especially the first year) is a golden time for exposure to auditory stimuli as the brain is  most plastic for learning speech and language skills [7, 8]. The rich language environment and perfect auditory access are vital components for a developing child [9]. 
To provide good auditory access, there is an absolute need for providing a suitable sensory aid (hearing aid or cochlear implant) as early as possible. Good auditory access is a key component prior to any successful auditory rehabilitation or early intervention [10]. Evaluating auditory access and auditory skills of infants and toddlers can be challenging. Their behavioral test results may be inconsistent [11]. In addition,  pure tone audiometry and speech recognition tests in quiet overlook auditory function in real-world situations; thus, may not be  good predictors of child’s auditory behavior [12]. 
Infant-Toddler Meaningful Auditory Integration Scale (IT-MAIS) is useful  for the quantitative evaluation of auditory behaviors in different situations. IT-MAIS (Zimmerman-Phillips 2000) is a Modification of the original scale (Meaningful Auditory Integration Scale; MAIS) [13]. This scale is actually a structured interview with parents. It consisted of 10 main probes that assess three areas: vocalization behavior; alertness to sounds; and deriving meaning from sound. For scoring, 0 (lowest) to 4 (highest) points can be designated to each probe. The time percentage spent by the child on auditory abilities is investigated and scored. Therefore, the maximum achievable score is 40. There are 5 response options to each question including never, rarely, occasionally, frequently, and always. The total score (20 questions for 10 probes) is calculated, ultimately. 
Since  the introduction of IT-MAIS, numerous studies  have  used this scale for determining hearing aid benefits, cochlear implant candidacy and cochlear implant outcome measures.  In general, it is considered as a useful tool for evaluating audiological outcomes in children younger than 3 years of age [14-21]. It is translated and validated in many languages including Arabic, Italian, Chinese,  German, Polish, and British English [21-23]. 
IT-MAIS test-retest reliability, Intraclass Correlation Coefficient (ICC), internal consistency (Cronbach’s alpha), and content validity (Pearson’s correlation confident) were 0.92, 0.89, 26.84 and 0.84, respectively [13]. 
The present study aimed to translate and validate IT-MAIS in Persian speakers. The forward-backward translation method was applied. This study was conducted with the assistance of one of the main developers of the original scale and under her official permission.
2. Methods
After contacting with the third author who is one of the main developers of the scale, and obtaining her permission, the scale was translated from English to Persian by 4 professionals including two audiologists and two speech-language pathologists (step 1: Forward translation). These professionals comprised  the expert committee throughout the study. In translation, there was a need for some cultural adaptations such as changing the probes’ examples. The translated scale was discussed with two audiologists and two speech-language pathologists familiar with the research method for improving these versions (step 2: Synthesis). After final approval, the resultant version was provided to a professional translator and a bilingual (Persian-English) speech-language pathologist who was not familiar with the original scale, to translate it into English (step 3: Backward translation). The expert committee compared the new backward translation with the original one to ensure that it has the same semantic value as the original scale (step 4: Expert committee discussion).
The translation was forwarded to the author and she approved the scale. Then, the Persian-IT-MAIS was distributed among 5 audiologists, 6 speech-language pathologists, and 5 mothers of hearing impaired children for evaluating its face validity. The explored factors included clarity, simplicity, and relevance. Their comments were taken into consideration and were cross-checked by the author. Finally, 17 Persian infants and toddlers with normal hearing (10 males and 7 females with a Mean±SD age of 28.29±7.37 months) and 17 hearing aid user Persian infants and toddlers with a profound hearing loss (10 males and 7 females, with a Mean±SD age of 23.23±5.93 months) were enrolled in the pilot study (step 5: testing  the pre-final version). 
Only children with native Persian speaking parents were enrolled. All the normal hearing children were recruited from those who had passed the universal newborn hearing screening and their hearing status were considered normal based on audiological documents. Moreover, children with hearing impairment risk factors based on the Joint Committee on Infant Hearing (JCIH) were excluded from the study. 
Research ethics based on the Declaration of Helsinki were observed. All evaluations were non-invasive. Informed consent was obtained from the mothers of hearing-impaired children, and other subjects. In the normal hearing children, only 9 items out of total 10 probes of IT-MAIS were demonstrated. This was because the first item, ‘is the child’s vocal behavior affected while wearing his/her sensory aid (hearing aid or cochlear implant)?’ was not included and  inapplicable to the normal hearing children. Children with profound hearing loss had the auditory thresholds of ≥90 dBHL in behavioral audiology tests and Auditory Brainstem Response (ABR) based on the records. 
They did not have any additional disabilities. The test items were asked by the mothers as a structured interview. The Mean±SD age of children’s mothers was 45.5±5 years and all of them had at least 12 years of academic education. The interviewer was a trained speech-language pathologist with 16 years of experience in the field of auditory rehabilitation. The interviews were conducted in a room without distracters. The children’s mothers had no time limit to think, ask questions and respond, during interviews. 
The test terminology was altered based on the mothers’ suggestions and the final version of the scale was formed. The three main areas of the scale (vocalization behavior; alertness to sounds; and deriving meaning from sound) were analyzed concurrently. Internal consistency indicates to what extend each item measures the same underlying construct. For this evaluation, the IT-MAIS-F scores in 17  normal hearing infants and toddlers were investigated. 
3. Results
The Mann-Whitney U test was performed on items 2 to 10 of the scale, because  probe 1 was only used in children with hearing loss. There was a significant difference (P≤0.001) between the two groups in all items (Table 1). Cronbach’s alpha confident  was applied for evaluating the internal consistency of the scale. Cronbach’s alpha from 0.7 to 0.9 were considered in the range of acceptable internal consistency. The overall score Cronbach’s alpha was 0.93. The results of inter-item reliability were acceptable (Table 2).

4. Discussion
In this study, IT-MAIS-F was translated and validated into Persian and examined on 17 hearing impaired and 17 normal hearing children. The results revealed that IT-MAIS-F is a reliable scale applicable in Persian speaking children. In face validity examination, all items were clear, simple, understandable, and relevant to the scale initial aim. All of the studied children’s’ mothers were comfortable answering the probes. Based on the experts’ report, the scale was easy to administer and its completion took about 20 to 30 minutes. 
IT-MAIS-F internal consistency was acceptable (α=0.93 for the total score and 0.92, 0.91 for detection and recognition subscales, respectively). In a study on the development of Italian IT-MAIS, internal consistency satisfactorily extended from α=0.87 for the detection to α=0.92 for the recognition category [24]. In another study on the IT-MAIS on a Chinese population, Cronbach’s alpha was obtained as 0.96 for the total score. Zhong et al. studied the reliability and validity of the Chinese version of IT-MAIS in 300 children with a cochlear implant and Cronbach’s alpha coefficient equal to  0.836 for the total score [13]. 
These results suggest that this scale is a reliable and valid tool. The internal consistency and item reliability of the Chinese version of IT-MAIS was comparable to the German, Polish, and British English versions of IT-MAIS scale. These similar results among different cultures and languages might be attributable to the same development course of the early pre-lingual auditory function in all infants. All items of the original scale were kept in the cross-language version of IT-MAIS [21].
In the present study, there was a significant difference between the mean scores of the scale in normal hearing and hearing impaired children. The significant differences in  IT-MAIS scores in children with profound hearing loss and in normal hearing children suggest that the IT-MAIS-F could potentially be a useful tool in assessing auditory performance and  monitoring  sensory device benefits in hearing impaired children. This result is in agreement with the Italian version of IT-MAIS [24].
IT-MAIS can clarify normative auditory skill development and be used as an outcome measurement tool for the evaluation of early hearing intervention, hearing aid and cochlear implant [14]. IT-MAIS is the most frequently used parental questionnaire in the USA, and widely used in different parts of the world to help determine cochlear implant candidacy and monitoring listening development after cochlear implant surgery in children with hearing loss [24]. This scale has been widely used in assessing the progress of auditory performance in very young children [25]. 
This study suggested that IT-MAIS-F can be a reliable and valid tool for the evaluation of the auditory function of children. However, the sample size of the study was small. Studies with larger sample sizes are recommended on this subject. In addition, test-retest reliability of the scale was not studied.
5. Conclusion
 The Persian versions of IT-MAIS (IT-MAIS-F) has a high internal consistency and validity which make it a reliable and useful tool for evaluating auditory functions among infants and toddlers.
Ethical Considerations
Compliance with ethical guidelines
This study followed ethical guidelines of Helsinki declarations.
Funding
This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.
Authors contributions
Conceptualization: Akbar Darouie, Mamak Joulaie, Farzaneh Zamiri Abdollahi, Tayebeh Ahmadi; Methodology: Akbar Darouie, Mamak Joulaie, Farzaneh Zamiri Abdollahi, Tayebeh Ahmadi; Software: Akbar Darouie, Mamak Joulaie, Farzaneh Zamiri Abdollahi, Amy McConkey Robbins, Tayebeh Ahmadi; Validation: Akbar Darouie, Mamak Joulaie, Farzaneh Zamiri Abdollahi, Amy McConkey Robbins, Tayebeh Ahmadi; Formal analysis: Mamak Joulaie, Farzaneh Zamiri Abdollahi, Amy McConkey Robbins; Investigation: Mamak Joulaie, Farzaneh Zamiri Abdollahi, Somayeh Zarepour; Resources: Mamak Joulaie, Farzaneh Zamiri Abdollahi, Somayeh Zarepour; Data curation: Somayeh Zarepour; Writing–original draft preparation: Mamak Joulaie, Farzaneh Zamiri Abdollahi, Amy McConkey Robbins; Writing–review & editing: Mamak Joulaie, Farzaneh Zamiri Abdollahi; Visualization: Mamak Joulaie, Farzaneh Zamiri Abdollahi; Supervision: Akbar Darouie; and Project administration: Akbar Darouie.
Conflict of interest
The authors declare no conflict of interest.
Acknowledgements
We sincerely thank the mothers of hearing-impaired children, who participated in the current study.


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