1- Secondary Objectives: How will the study improve the quality of life in children? This should be apparent in the methodology

2- Background is too concise.

- More details is required to explain the current OM-6 questionnaire, e.g. in which language is the questionnaire, benefits, objectives, shortcomings.

- Also, are there other Arabic questionnaires?

- What is the gap of knowledge that this study will fill?

- How will the investigators explore the underlying factor structure?

- The questionnaire cannot be applied to children with OM before it is validated and this study should validate it first before application.

3- How was the sample size calculated needs details.  Which "Reference" was used; what was the reference topic?

- One of the attachments has a sample size calculation and the text should be added to the protocol.

- Additionally the sample size calculation includes 100 cases per group, but the protocol does not explain what the 2 groups are.

4- Age of participants is in months or years?

5- Inclusion criteria are not descriptive of the population, e.g. are the participants sick or healthy? Which gender?

6- Methodology

- Clinical and laboratory data should include details of when and who will perform the tympanometry. It should also include the questionnaire and all other procedures, if any.

- Methods are missing completely from the protocol: What will be done to the children and how the data be analyzed to validate the questionnaire?

7- Risks There is not a research with no risks. The time spent for tympanometry and for completing the questionnaire is an inconvenience that is calculated towards risk. What about tympanometery?

8- Confidentiality: The results of the tests needs to be protected. So N/A is not an appropriate answer.

9-The investigator mentioned that the protocol was not reviewed by the science committee, yet attached the Department approval.

10- Arabic consent is not complete.