Analysis of Musical and Voice Skills in Children and Adult Cochlear Implant Users

METHODOLOGY

Design Cross-sectional study in which both implanted patients and control subjects without hearing loss were tested only once.

Scope and study subjects Prior to the inclusion of subjects in the study, the approval of the Ethics Committee of the Hospital Universitario La Paz (HULP) will be required.

STUDY GROUP (Implanted group) Adult patients (≥18 years) with postlingual hearing loss and children (between 6 and 17 years) with prelingual or perilingual hearing loss who have received a CI before the age of 3 years.

Patients who have received a CI from 2000 to January 2023 will be included as potential candidates for participation. Currently 76 subjects aged 6-17 years implanted before the age of 3 years and 231 post-lingual adults are identified in the database, to which post-lingual adults implanted in the next 2 years should be added, so that after one year of follow up they can participate in the study.

Inclusion criteria:

* Minimum age of 6 years. * Patients aged 6-17 years must have been implanted before the age of 3 years (to ensure adequate CI performance). * Minimum 12 months experience with the device * Indications: unilateral (one CI), bilateral (two CIs), bimodal (one CI in one ear and a hearing aid in the other) * At least 80% of electrodes active at the time of assessment. * Fluency in Spanish * Signed and dated informed consent prior to starting any study procedure.

Exclusion criteria:

* Not meet inclusion criteria. * Prelingual or perilingual adults. * Disability in addition to hearing impairment (e.g., mental disability). Routine visits in the HULP or at their CI fitting sessions will be used as an opportunity to contact patients and propose their participation.

CONTROL GROUP The control group will be composed of subjects over 6 years of age without hearing impairment, without a disability that prevents them from taking the tests and who have socio-demographic characteristics similar to those of the study group. They will be included from the ENT Department where they will have come either with another type of medical condition other than hearing loss, or accompanying patients. Hospital La Paz staff (or family members) who wish to carry out the tests may also be included. They must be fluent in Spanish to ensure that they understand the study and its purpose. To confirm that the control group does not have hearing impairment, they will undergo tonal audiometry in both ears, whose tonal threshold should be ≤30dB in the conversational frequencies of 500, 1000 and 2000Hz.

Socio-demographic and clinical variables Study group: affiliation data (current age, age at implantation, sex, education level), hearing loss data (aetiology, duration of hearing loss, type and degree of hearing loss, worst ear), surgery data (type of implant and electrode array used, complete or incomplete insertion, side implanted, date of intervention), postoperative complications. These data will be collected from the patients' medical records. In addition, fititing data (number of active electrodes, processor model) and audiological tests with the CI will be collected.

Control group: age, sex, associated pathology(ies), level of education.

Outcome variables

1. Scoring of the music-related quality of life questionnaire (MuRQoL), the Munich music questionnaire (MuMu) and the questionnaire developed for subjects aged 6-17 years (see description). 2. Validation of the music-related quality of life questionnaire (MuRQoL) in adult population. 3. Score obtained in the "discovery" level with the Meludia music tool (see description). 4. Parameters to assess voice quality:

Spoken voice: Vocal inability index, Maximum phonation time, Fundamental voice frequency, Jitter, Shimmer, Harmonics to noise ratio (HNR), Smoothed cepstral peak (CPPS) and Spectrogram according to Yanagihara's classification.

Sung voice: Pitch (relative to the note emitted by a keyboard), CPPS and Singing power ratio (SPR). 5. Impact of demographic and audiological factors on the results of the music perception questionnaires as well as on the results of the Meludia tool and the acoustic analysis of the implanted patients and comparison with the normal hearing control group.

Description of the measurement instruments

1. \- MuMu Questionnaire: The Munich Music Questionnaire was especially developed for the adult CI users population with postlingual hearing loss. It includes questions that address past and present activities related to the habit of listening to music. We will use the abbreviated version which contains 9 questions on music listening habits in relation to various musical styles, different instruments and participation in musical activities at different times in the life of implanted patients. It offers many response options, from the "yes or no" format to rating scales and multiple choice questions with the possibility to tick as many options as necessary (e.g. "How often do you listen and/or have you listened to music", on a scale of 0-10; "Why do you listen to music", with the options of "for pleasure", "professional reasons", "emotional satisfaction", "to relax"). It is translated and validated in Spanish (developed by S.J. Brockmeier and adapted by Ana Fuster. Info: https://www.medel.com/support/rehab/rehabilitation-downloads). 2. MuRQoL Questionnaire: The concept of music related quality of life (MuRQoL) was initially defined as the impact of listening skills on the quality of life of implanted patients. To work on this concept, groups of adult CI users created the questions, thus ensuring content validity, differing from previous studies in that users were not involved in the initial question generation process. The MuRQoL questionnaire addresses novel aspects of musical experience, such as the ability to hear whether one is singing at the right pitch. It uses a 5-point Likert-type scale or satisfaction scale, which includes a range of opinions allowing for a greater degree of specificity than a yes/no question. Five of the 18 questions included are novel among music questionnaires designed for adult CI users, (question 4 - "can you recognise words in songs?", 6, 9, 10 and 15 - "do you listen to music while travelling, e.g. in the car?"). This is important for assessing musical experiences that have not been measured by previous questionnaires. On the other hand, several questions are similar to those of other questionnaires, e.g. question 18 is also reflected in the MuMu test ("Do you sing, play a musical instrument or whistle?"). The questionnaire consists of two parts with the same 18 questions each, divided into musical perception and musical engagement. Part I of the questionnaire asks about musical experiences, e.g. "Can you differentiate between different rhythms in music? Part II asks about the importance of music listening skills, attitudes towards music and musical activities for the implant recipient, e.g. "How important is it for you to be able to distinguish different rhythms in music?" Dritsakis G, van Besouw RM, Kitterick P, Verschuur CA. A Music-Related Quality of Life Measure to Guide Music Rehabilitation for Adult Cochlear Implant Users. American journal of audiology 2017;26:268-282. 3. Questionnaire for subjects aged 6-17 years: After reviewing the existing literature, we did not find any questionnaire suitable both in language and in the form of scores for subjects aged 6-17 years. Therefore, we have made a selection of questions that have already been used by other authors and that encompass aspects of musical interests, musical profile, role of music and music-related activities \[Pacheco et al., 2020; Vannatta-Hall, 2010; Waaramaa et al., 2018\] (See Annex).Pacheco L, Miguel JHS, Gil D. Musical stimulation proposal for hearing impaired children: case reports. CoDAS 2020;32:e20190139; Vannatta-Hall JE: Music education in early childhood teacher education: the impact of a music methods course on pre-service teachers' perceived confidence and competence to teach music. University of Illinois at Urbana-Champaign, 2010; Waaramaa T, Kukkonen T, Mykkänen S, Geneid A. Vocal Emotion Identification by Children Using Cochlear Implants, Relations to Voice Quality, and Musical Interests. Journal of speech, language, and hearing research : JSLHR 2018;61:973-985. 4. Meludia: The music tool Meludia (www.meludia.com), available in Spanish, uses interactive music listening exercises of progressive difficulty for both children and adults. It is based on listening and responding. Meludia poses questions using sounds and colourful graphic designs, which after listening carefully (patients controlled directly and those implanted through the connection cable that allows direct listening through the audio processor) are selected with the PC mouse by clicking on the button that best corresponds to what has just been heard. Different categories are evaluated: Rhythm (indicate how many percussion beats are heard, from 1 to 8), Melody (indicate whether the melody heard is ascending or descending), Density (indicate how many sounds are heard simultaneously, one or several), Stability (indicate whether the sound heard is chaotic or not; that is, whether it gives a feeling of stability or instability) and Spatialisation (indicate whether the second note has a higher or lower pitch than the first one). The tool consists of 4 modules: Discovery, Intermediate, Advanced and Expert. In this study we will initially work with the Discovery module, which consists of 25 exercises (5 for each of the 5 categories indicated above) (see appendix). Scores (between 1 and 3) will be collected for each of the exercises, as well as whether or not each category is completed. A maximum of 4 attempts will be allowed in each of the exercises. If after the 4 attempts the subject is not able to obtain at least a score of 1, the test shall stop in that category and move on to the next category. The test shall start with the "rhythm" category, which is considered the easiest category. 5. Acoustic analysis of the voice: the Praat programme will be used (developed by Paul Boersma and David Weenink of the University of Amsterdam), which is the most widely used in publications related to the subject 6 and whose values have been compared with other programmes validated in Spanish 7.

The sound signal will be collected with a Saramonic International microphone (3.5 mm) and a spoken voice recording will be made according to the protocol of the European Society of Laryngology 8: * Vowel /a/ held for at least 3 seconds. * Phonetically balanced text ("Platero y yo" by Juan Ramón Jiménez). * Voice recording sung with the first phrase of the popular song "Cumpleaños feliz" prolonging the last vowel /i/ for at least 3 seconds.

The parameters to be analysed in order to evaluate the quality of the voice are the following:

Spoken voice: Vocal incapacity index, Maximum phonation time, Fundamental frequency of the voice, Jitter, Shimmer, Harmonics to noise ratio (HNR), Smoothed cepstral peak (CPPS) and Spectrogram according to Yanagihara's classification.

Sung voice: Pitch (with respect to the note emitted by a keyboard), CPPS and Singing power ratio (SPR). 6. \- Description of the audiological tests: the study group will undergo tonal and speech audiometry in free field to obtain objective values of their CI performance. This will be carried out in a double-walled acoustically insulated booth and the subjects will be seated 1 m away from the speakers at 0º azimuth. If a patient has better hearing in the non-implanted ear, this ear will be masked during the test thus eliminating the perception of the "good ear" and assessing CI performance only, and if the patient is wearing a hearing aid it will be removed for the test. For tonal audiometry the frequencies of 250, 500, 1000, 2000, 4000 and 6000Hz will be evaluated and for statistical purposes the PTA4 value (average thresholds at 500,1000, 2000 and 4

• The impact of hearing with CI on the perception and enjoyment of music. [Срок оценки: 3 years]